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Electronic Code of Federal Regulations

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e-CFR Data is current as of September 18, 2014

Title 21Chapter ISubchapter HPart 888


TITLE 21—Food and Drugs

CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)

SUBCHAPTER H—MEDICAL DEVICES

PART 888—ORTHOPEDIC DEVICES

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Subpart A—GENERAL PROVISIONS

§888.1
Scope.
§888.3
Effective dates of requirement for premarket approval.
§888.5
Resurfacing technique.
§888.6
Degree of constraint.
§888.9
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

§888.1100
Arthroscope.
§888.1240
AC-powered dynamometer.
§888.1250
Nonpowered dynamometer.
§888.1500
Goniometer.
§888.1520
Nonpowered goniometer.
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Subpart C—[RESERVED]

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Subpart D—PROSTHETIC DEVICES

§888.3000
Bone cap.
§888.3010
Bone fixation cerclage.
§888.3015
Bone heterograft.
§888.3020
Intramedullary fixation rod.
§888.3025
Passive tendon prosthesis.
§888.3027
Polymethylmethacrylate (PMMA) bone cement.
§888.3030
Single/multiple component metallic bone fixation appliances and accessories.
§888.3040
Smooth or threaded metallic bone fixation fastener.
§888.3045
Resorbable calcium salt bone void filler device.
§888.3050
Spinal interlaminal fixation orthosis.
§888.3060
Spinal intervertebral body fixation orthosis.
§888.3070
Pedicle screw spinal system.
§888.3080
Intervertebral body fusion device.
§888.3100
Ankle joint metal/composite semi-constrained cemented prosthesis.
§888.3110
Ankle joint metal/polymer semi-constrained cemented prosthesis.
§888.3120
Ankle joint metal/polymer non-constrained cemented prosthesis.
§888.3150
Elbow joint metal/polymer constrained cemented prosthesis.
§888.3160
Elbow joint metal/polymer semi-constrained cemented prosthesis.
§888.3170
Elbow joint radial (hemi-elbow) polymer prosthesis.
§888.3180
Elbow joint humeral (hemi-elbow) metallic uncemented prosthesis.
§888.3200
Finger joint metal/metal constrained uncemented prosthesis.
§888.3210
Finger joint metal/metal constrained cemented prosthesis.
§888.3220
Finger joint metal/polymer constrained cemented prosthesis.
§888.3230
Finger joint polymer constrained prosthesis.
§888.3300
Hip joint metal constrained cemented or uncemented prosthesis.
§888.3310
Hip joint metal/polymer constrained cemented or uncemented prosthesis.
§888.3320
Hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis.
§888.3330
Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.
§888.3340
Hip joint metal/composite semi-constrained cemented prosthesis.
§888.3350
Hip joint metal/polymer semi-constrained cemented prosthesis.
§888.3353
Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
§888.3358
Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
§888.3360
Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.
§888.3370
Hip joint (hemi-hip) acetabular metal cemented prosthesis.
§888.3380
Hip joint femoral (hemi-hip) trunnion-bearing metal/polyacetal cemented prosthesis.
§888.3390
Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis.
§888.3400
Hip joint femoral (hemi-hip) metallic resurfacing prosthesis.
§888.3410
Hip joint metal/polymer or ceramic/polymer semiconstrained resurfacing cemented prosthesis.
§888.3480
Knee joint femorotibial metallic constrained cemented prosthesis.
§888.3490
Knee joint femorotibial metal/composite non-constrained cemented prosthesis.
§888.3500
Knee joint femorotibial metal/composite semi-constrained cemented prosthesis.
§888.3510
Knee joint femorotibial metal/polymer constrained cemented prosthesis.
§888.3520
Knee joint femorotibial metal/polymer non-constrained cemented prosthesis.
§888.3530
Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis.
§888.3535
Knee joint femorotibial (uni-compartmental) metal/polymer porous-coated uncemented prosthesis.
§888.3540
Knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis.
§888.3550
Knee joint patellofemorotibial polymer/metal/metal constrained cemented prosthesis.
§888.3560
Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
§888.3565
Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.
§888.3570
Knee joint femoral (hemi-knee) metallic uncemented prosthesis.
§888.3580
Knee joint patellar (hemi-knee) metallic resurfacing uncemented prosthesis.
§888.3590
Knee joint tibial (hemi-knee) metallic resurfacing uncemented prosthesis.
§888.3640
Shoulder joint metal/metal or metal/polymer constrained cemented prosthesis.
§888.3650
Shoulder joint metal/polymer non-constrained cemented prosthesis.
§888.3660
Shoulder joint metal/polymer semi-constrained cemented prosthesis.
§888.3670
Shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis.
§888.3680
Shoulder joint glenoid (hemi-shoulder) metallic cemented prosthesis.
§888.3690
Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis.
§888.3720
Toe joint polymer constrained prosthesis.
§888.3730
Toe joint phalangeal (hemi-toe) polymer prosthesis.
§888.3750
Wrist joint carpal lunate polymer prosthesis.
§888.3760
Wrist joint carpal scaphoid polymer prosthesis.
§888.3770
Wrist joint carpal trapezium polymer prosthesis.
§888.3780
Wrist joint polymer constrained prosthesis.
§888.3790
Wrist joint metal constrained cemented prosthesis.
§888.3800
Wrist joint metal/polymer semi-constrained cemented prosthesis.
§888.3810
Wrist joint ulnar (hemi-wrist) polymer prosthesis.
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Subpart E—SURGICAL DEVICES

§888.4150
Calipers for clinical use.
§888.4200
Cement dispenser.
§888.4210
Cement mixer for clinical use.
§888.4220
Cement monomer vapor evacuator.
§888.4230
Cement ventilation tube.
§888.4300
Depth gauge for clinical use.
§888.4540
Orthopedic manual surgical instrument.
§888.4580
Sonic surgical instrument and accessories/attachments.
§888.4600
Protractor for clinical use.
§888.4800
Template for clinical use.
§888.5850
Nonpowered orthopedic traction apparatus and accessories.
§888.5890
Noninvasive traction component.
§888.5940
Cast component.
§888.5960
Cast removal instrument.
§888.5980
Manual cast application and removal instrument.


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