21 C.F.R. PART 888--ORTHOPEDIC DEVICES
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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| 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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