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Title 21
PART 888 SUBPART D
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Volume 8
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Chapter I
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Subchapter H
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Part 888
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Subpart D
Subpart D - Prosthetic Devices
21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
52 FR 33702, Sept. 4, 1987, unless otherwise noted.
21:8.0.1.1.31.4.1.1
SECTION 888.3000
888.3000 Bone cap.
21:8.0.1.1.31.4.1.2
SECTION 888.3010
888.3010 Bone fixation cerclage.
21:8.0.1.1.31.4.1.3
SECTION 888.3015
888.3015 Bone heterograft.
21:8.0.1.1.31.4.1.4
SECTION 888.3020
888.3020 Intramedullary fixation rod.
21:8.0.1.1.31.4.1.5
SECTION 888.3023
888.3023 In vivo cured intramedullary fixation rod.
21:8.0.1.1.31.4.1.6
SECTION 888.3025
888.3025 Passive tendon prosthesis.
21:8.0.1.1.31.4.1.7
SECTION 888.3027
888.3027 Polymethylmethacrylate (PMMA) bone cement.
21:8.0.1.1.31.4.1.8
SECTION 888.3030
888.3030 Single/multiple component metallic bone fixation appliances and accessories.
21:8.0.1.1.31.4.1.9
SECTION 888.3040
888.3040 Smooth or threaded metallic bone fixation fastener.
21:8.0.1.1.31.4.1.10
SECTION 888.3045
888.3045 Resorbable calcium salt bone void filler device.
21:8.0.1.1.31.4.1.11
SECTION 888.3050
888.3050 Spinal interlaminal fixation orthosis.
21:8.0.1.1.31.4.1.12
SECTION 888.3060
888.3060 Spinal intervertebral body fixation orthosis.
21:8.0.1.1.31.4.1.13
SECTION 888.3070
888.3070 Thoracolumbosacral pedicle screw system.
21:8.0.1.1.31.4.1.14
SECTION 888.3075
888.3075 Posterior cervical screw system.
21:8.0.1.1.31.4.1.15
SECTION 888.3080
888.3080 Intervertebral body fusion device.
21:8.0.1.1.31.4.1.16
SECTION 888.3100
888.3100 Ankle joint metal/composite semi-constrained cemented prosthesis.
21:8.0.1.1.31.4.1.17
SECTION 888.3110
888.3110 Ankle joint metal/polymer semi-constrained cemented prosthesis.
21:8.0.1.1.31.4.1.18
SECTION 888.3120
888.3120 Ankle joint metal/polymer non-constrained cemented prosthesis.
21:8.0.1.1.31.4.1.19
SECTION 888.3150
888.3150 Elbow joint metal/polymer constrained cemented prosthesis.
21:8.0.1.1.31.4.1.20
SECTION 888.3160
888.3160 Elbow joint metal/polymer semi-constrained cemented prosthesis.
21:8.0.1.1.31.4.1.21
SECTION 888.3170
888.3170 Elbow joint radial (hemi-elbow) polymer prosthesis.
21:8.0.1.1.31.4.1.22
SECTION 888.3180
888.3180 Elbow joint humeral (hemi-elbow) metallic uncemented prosthesis.
21:8.0.1.1.31.4.1.23
SECTION 888.3200
888.3200 Finger joint metal/metal constrained uncemented prosthesis.
21:8.0.1.1.31.4.1.24
SECTION 888.3210
888.3210 Finger joint metal/metal constrained cemented prosthesis.
21:8.0.1.1.31.4.1.25
SECTION 888.3220
888.3220 Finger joint metal/polymer constrained cemented prosthesis.
21:8.0.1.1.31.4.1.26
SECTION 888.3230
888.3230 Finger joint polymer constrained prosthesis.
21:8.0.1.1.31.4.1.27
SECTION 888.3300
888.3300 Hip joint metal constrained cemented or uncemented prosthesis.
21:8.0.1.1.31.4.1.28
SECTION 888.3310
888.3310 Hip joint metal/polymer constrained cemented or uncemented prosthesis.
21:8.0.1.1.31.4.1.29
SECTION 888.3320
888.3320 Hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis.
21:8.0.1.1.31.4.1.30
SECTION 888.3330
888.3330 Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.
21:8.0.1.1.31.4.1.31
SECTION 888.3340
888.3340 Hip joint metal/composite semi-constrained cemented prosthesis.
21:8.0.1.1.31.4.1.32
SECTION 888.3350
888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
21:8.0.1.1.31.4.1.33
SECTION 888.3353
888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
21:8.0.1.1.31.4.1.34
SECTION 888.3358
888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
21:8.0.1.1.31.4.1.35
SECTION 888.3360
888.3360 Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.
21:8.0.1.1.31.4.1.36
SECTION 888.3370
888.3370 Hip joint (hemi-hip) acetabular metal cemented prosthesis.
21:8.0.1.1.31.4.1.37
SECTION 888.3380
888.3380 Hip joint femoral (hemi-hip) trunnion-bearing metal/polyacetal cemented prosthesis.
21:8.0.1.1.31.4.1.38
SECTION 888.3390
888.3390 Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis.
21:8.0.1.1.31.4.1.39
SECTION 888.3400
888.3400 Hip joint femoral (hemi-hip) metallic resurfacing prosthesis.
21:8.0.1.1.31.4.1.40
SECTION 888.3410
888.3410 Hip joint metal/polymer or ceramic/polymer semiconstrained resurfacing cemented prosthesis.
21:8.0.1.1.31.4.1.41
SECTION 888.3480
888.3480 Knee joint femorotibial metallic constrained cemented prosthesis.
21:8.0.1.1.31.4.1.42
SECTION 888.3490
888.3490 Knee joint femorotibial metal/composite non-constrained cemented prosthesis.
21:8.0.1.1.31.4.1.43
SECTION 888.3500
888.3500 Knee joint femorotibial metal/composite semi-constrained cemented prosthesis.
21:8.0.1.1.31.4.1.44
SECTION 888.3510
888.3510 Knee joint femorotibial metal/polymer constrained cemented prosthesis.
21:8.0.1.1.31.4.1.45
SECTION 888.3520
888.3520 Knee joint femorotibial metal/polymer non-constrained cemented prosthesis.
21:8.0.1.1.31.4.1.46
SECTION 888.3530
888.3530 Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis.
21:8.0.1.1.31.4.1.47
SECTION 888.3535
888.3535 Knee joint femorotibial (uni-compartmental) metal/polymer porous-coated uncemented prosthesis.
21:8.0.1.1.31.4.1.48
SECTION 888.3540
888.3540 Knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis.
21:8.0.1.1.31.4.1.49
SECTION 888.3550
888.3550 Knee joint patellofemorotibial polymer/metal/metal constrained cemented prosthesis.
21:8.0.1.1.31.4.1.50
SECTION 888.3560
888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
21:8.0.1.1.31.4.1.51
SECTION 888.3565
888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.
21:8.0.1.1.31.4.1.52
SECTION 888.3570
888.3570 Knee joint femoral (hemi-knee) metallic uncemented prosthesis.
21:8.0.1.1.31.4.1.53
SECTION 888.3580
888.3580 Knee joint patellar (hemi-knee) metallic resurfacing uncemented prosthesis.
21:8.0.1.1.31.4.1.54
SECTION 888.3590
888.3590 Knee joint tibial (hemi-knee) metallic resurfacing uncemented prosthesis.
21:8.0.1.1.31.4.1.55
SECTION 888.3640
888.3640 Shoulder joint metal/metal or metal/polymer constrained cemented prosthesis.
21:8.0.1.1.31.4.1.56
SECTION 888.3650
888.3650 Shoulder joint metal/polymer non-constrained cemented prosthesis.
21:8.0.1.1.31.4.1.57
SECTION 888.3660
888.3660 Shoulder joint metal/polymer semi-constrained cemented prosthesis.
21:8.0.1.1.31.4.1.58
SECTION 888.3670
888.3670 Shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis.
21:8.0.1.1.31.4.1.59
SECTION 888.3680
888.3680 Shoulder joint glenoid (hemi-shoulder) metallic cemented prosthesis.
21:8.0.1.1.31.4.1.60
SECTION 888.3690
888.3690 Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis.
21:8.0.1.1.31.4.1.61
SECTION 888.3720
888.3720 Toe joint polymer constrained prosthesis.
21:8.0.1.1.31.4.1.62
SECTION 888.3730
888.3730 Toe joint phalangeal (hemi-toe) polymer prosthesis.
21:8.0.1.1.31.4.1.63
SECTION 888.3750
888.3750 Wrist joint carpal lunate polymer prosthesis.
21:8.0.1.1.31.4.1.64
SECTION 888.3760
888.3760 Wrist joint carpal scaphoid polymer prosthesis.
21:8.0.1.1.31.4.1.65
SECTION 888.3770
888.3770 Wrist joint carpal trapezium polymer prosthesis.
21:8.0.1.1.31.4.1.66
SECTION 888.3780
888.3780 Wrist joint polymer constrained prosthesis.
21:8.0.1.1.31.4.1.67
SECTION 888.3790
888.3790 Wrist joint metal constrained cemented prosthesis.
21:8.0.1.1.31.4.1.68
SECTION 888.3800
888.3800 Wrist joint metal/polymer semi-constrained cemented prosthesis.
21:8.0.1.1.31.4.1.69
SECTION 888.3810
888.3810 Wrist joint ulnar (hemi-wrist) polymer prosthesis.