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Home Page > Executive Branch > Code of Federal Regulations > Electronic Code of Federal Regulations
e-CFR Data is current as of February 4, 2010
TITLE 21--Food and Drugs
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES
PART 888--ORTHOPEDIC DEVICES
Subpart A--GENERAL PROVISIONS
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| Effective dates of requirement for premarket approval. |
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| Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). |
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Subpart B--DIAGNOSTIC DEVICES
Subpart C--[RESERVED]
Subpart D--PROSTHETIC DEVICES
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| Intramedullary fixation rod. |
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| Passive tendon prosthesis. |
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| Polymethylmethacrylate (PMMA) bone cement. |
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| Single/multiple component metallic bone fixation appliances and accessories. |
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| Smooth or threaded metallic bone fixation fastener. |
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| Resorbable calcium salt bone void filler device. |
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| Spinal interlaminal fixation orthosis. |
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| Spinal intervertebral body fixation orthosis. |
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| Pedicle screw spinal system. |
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| Intervertebral body fusion device. |
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| Ankle joint metal/composite semi-constrained cemented prosthesis. |
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| Ankle joint metal/polymer semi-constrained cemented prosthesis. |
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| Ankle joint metal/polymer non-constrained cemented prosthesis. |
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| Elbow joint metal/polymer constrained cemented prosthesis. |
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| Elbow joint metal/polymer semi-constrained cemented prosthesis. |
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| Elbow joint radial (hemi-elbow) polymer prosthesis. |
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| Elbow joint humeral (hemi-elbow) metallic uncemented prosthesis. |
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| Finger joint metal/metal constrained uncemented prosthesis. |
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| Finger joint metal/metal constrained cemented prosthesis. |
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| Finger joint metal/polymer constrained cemented prosthesis. |
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| Finger joint polymer constrained prosthesis. |
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| Hip joint metal constrained cemented or uncemented prosthesis. |
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| Hip joint metal/polymer constrained cemented or uncemented prosthesis. |
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| Hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis. |
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| Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis. |
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| Hip joint metal/composite semi-constrained cemented prosthesis. |
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| Hip joint metal/polymer semi-constrained cemented prosthesis. |
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| Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis. |
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| Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis. |
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| Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis. |
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| Hip joint (hemi-hip) acetabular metal cemented prosthesis. |
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| Hip joint femoral (hemi-hip) trunnion-bearing metal/polyacetal cemented prosthesis. |
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| Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis. |
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| Hip joint femoral (hemi-hip) metallic resurfacing prosthesis. |
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| Hip joint metal/polymer or ceramic/polymer semiconstrained resurfacing cemented prosthesis. |
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| Knee joint femorotibial metallic constrained cemented prosthesis. |
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| Knee joint femorotibial metal/composite non-constrained cemented prosthesis. |
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| Knee joint femorotibial metal/composite semi-constrained cemented prosthesis. |
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| Knee joint femorotibial metal/polymer constrained cemented prosthesis. |
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| Knee joint femorotibial metal/polymer non-constrained cemented prosthesis. |
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| Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis. |
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| Knee joint femorotibial (uni-compartmental) metal/polymer porous-coated uncemented prosthesis. |
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| Knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis. |
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| Knee joint patellofemorotibial polymer/metal/metal constrained cemented prosthesis. |
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| Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis. |
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| Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis. |
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| Knee joint femoral (hemi-knee) metallic uncemented prosthesis. |
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| Knee joint patellar (hemi-knee) metallic resurfacing uncemented prosthesis. |
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| Knee joint tibial (hemi-knee) metallic resurfacing uncemented prosthesis. |
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| Shoulder joint metal/metal or metal/polymer constrained cemented prosthesis. |
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| Shoulder joint metal/polymer non-constrained cemented prosthesis. |
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| Shoulder joint metal/polymer semi-constrained cemented prosthesis. |
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| Shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis. |
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| Shoulder joint glenoid (hemi-shoulder) metallic cemented prosthesis. |
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| Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis. |
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| Toe joint polymer constrained prosthesis. |
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| Toe joint phalangeal (hemi-toe) polymer prosthesis. |
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| Wrist joint carpal lunate polymer prosthesis. |
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| Wrist joint carpal scaphoid polymer prosthesis. |
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| Wrist joint carpal trapezium polymer prosthesis. |
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| Wrist joint polymer constrained prosthesis. |
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| Wrist joint metal constrained cemented prosthesis. |
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| Wrist joint metal/polymer semi-constrained cemented prosthesis. |
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| Wrist joint ulnar (hemi-wrist) polymer prosthesis. |
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Subpart E--SURGICAL DEVICES
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| Calipers for clinical use. |
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| Cement mixer for clinical use. |
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| Cement monomer vapor evacuator. |
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| Depth gauge for clinical use. |
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| Orthopedic manual surgical instrument. |
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| Sonic surgical instrument and accessories/attachments. |
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| Protractor for clinical use. |
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| Template for clinical use. |
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| Nonpowered orthopedic traction apparatus and accessories. |
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| Noninvasive traction component. |
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| Manual cast application and removal instrument. |
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