|
Section 888.1
|
Effective dates of requirement for premarket approval |
|
Section 888.3
|
Resurfacing technique |
|
Section 888.5
|
Degree of constraint |
|
Section 888.6
|
Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act) |
|
Section 888.9
|
Arthroscope |
|
Section 888.1100
|
AC-powered dynamometer |
|
Section 888.1240
|
Nonpowered dynamometer |
|
Section 888.1250
|
Goniometer |
|
Section 888.1500
|
Nonpowered goniometer |
|
Section 888.1520
|
Bone cap |
|
Section 888.3000
|
Bone fixation cerclage |
|
Section 888.3010
|
Bone heterograft |
|
Section 888.3015
|
Intramedullary fixation rod |
|
Section 888.3020
|
Passive tendon prosthesis |
|
Section 888.3025
|
Polymethylmethacrylate (PMMA) bone cement |
|
Section 888.3027
|
Single/multiple component metallic bone fixation appliances and accessories |
|
Section 888.3030
|
Smooth or threaded metallic bone fixation fastener |
|
Section 888.3040
|
Resorbable calcium salt bone void filler device |
|
Section 888.3045
|
Spinal interlaminal fixation orthosis |
|
Section 888.3050
|
Spinal intervertebral body fixation orthosis |
|
Section 888.3060
|
Pedicle screw spinal system |
|
Section 888.3070
|
Intervertebral body fusion device |
|
Section 888.3080
|
Ankle joint metal/composite semi-constrained cemented prosthesis |
|
Section 888.3100
|
Ankle joint metal/polymer semi-constrained cemented prosthesis |
|
Section 888.3110
|
Ankle joint metal/polymer non-constrained cemented prosthesis |
|
Section 888.3120
|
Elbow joint metal/polymer constrained cemented prosthesis |
|
Section 888.3150
|
Elbow joint metal/polymer semi-constrained cemented prosthesis |
|
Section 888.3160
|
Elbow joint radial (hemi-elbow) polymer prosthesis |
|
Section 888.3170
|
Elbow joint humeral (hemi-elbow) metallic uncemented prosthesis |
|
Section 888.3180
|
Finger joint metal/metal constrained uncemented prosthesis |
|
Section 888.3200
|
Finger joint metal/metal constrained cemented prosthesis |
|
Section 888.3210
|
Finger joint metal/polymer constrained cemented prosthesis |
|
Section 888.3220
|
Finger joint polymer constrained prosthesis |
|
Section 888.3230
|
Hip joint metal constrained cemented or uncemented prosthesis |
|
Section 888.3300
|
Hip joint metal/polymer constrained cemented or uncemented prosthesis |
|
Section 888.3310
|
Hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis |
|
Section 888.3320
|
Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis |
|
Section 888.3330
|
Hip joint metal/composite semi-constrained cemented prosthesis |
|
Section 888.3340
|
Hip joint metal/polymer semi-constrained cemented prosthesis |
|
Section 888.3350
|
Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis |
|
Section 888.3353
|
Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis |
|
Section 888.3358
|
Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis |
|
Section 888.3360
|
Hip joint (hemi-hip) acetabular metal cemented prosthesis |
|
Section 888.3370
|
Hip joint femoral (hemi-hip) trunnion-bearing metal/polyacetal cemented prosthesis |
|
Section 888.3380
|
Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis |
|
Section 888.3390
|
Hip joint femoral (hemi-hip) metallic resurfacing prosthesis |
|
Section 888.3400
|
Hip joint metal/polymer or ceramic/polymer semiconstrained resurfacing cemented prosthesis |
|
Section 888.3410
|
Knee joint femorotibial metallic constrained cemented prosthesis |
|
Section 888.3480
|
Knee joint femorotibial metal/composite non-constrained cemented prosthesis |
|
Section 888.3490
|
Knee joint femorotibial metal/composite semi-constrained cemented prosthesis |
|
Section 888.3500
|
Knee joint femorotibial metal/polymer constrained cemented prosthesis |
|
Section 888.3510
|
Knee joint femorotibial metal/polymer non-constrained cemented prosthesis |
|
Section 888.3520
|
Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis |
|
Section 888.3530
|
Knee joint femorotibial (uni-compartmental) metal/polymer porous-coated uncemented prosthesis |
|
Section 888.3535
|
Knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis |
|
Section 888.3540
|
Knee joint patellofemorotibial polymer/metal/metal constrained cemented prosthesis |
|
Section 888.3550
|
Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis |
|
Section 888.3560
|
Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis |
|
Section 888.3565
|
Knee joint femoral (hemi-knee) metallic uncemented |
|
Section 888.3570
|
Knee joint patellar (hemi-knee) metallic resurfacing uncemented prosthesis |
|
Section 888.3580
|
Knee joint tibial (hemi-knee) metallic resurfacing uncemented prosthesis |
|
Section 888.3590
|
Shoulder joint metal/metal or metal/polymer constrained cemented prosthesis |
|
Section 888.3640
|
Shoulder joint metal/polymer non-constrained cemented prosthesis |
|
Section 888.3650
|
Shoulder joint metal/polymer semi-constrained cemented prosthesis |
|
Section 888.3660
|
Shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis |
|
Section 888.3670
|
Shoulder joint glenoid (hemi-shoulder) metallic cemented prosthesis |
|
Section 888.3680
|
Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis |
|
Section 888.3690
|
Toe joint polymer constrained prosthesis |
|
Section 888.3720
|
Toe joint phalangeal (hemi-toe) polymer prosthesis |
|
Section 888.3730
|
Wrist joint carpal lunate polymer prosthesis |
|
Section 888.3750
|
Wrist joint carpal scaphoid polymer prosthesis |
|
Section 888.3760
|
Wrist joint carpal trapezium polymer prosthesis |
|
Section 888.3770
|
Wrist joint polymer constrained prosthesis |
|
Section 888.3780
|
Wrist joint metal constrained cemented prosthesis |
|
Section 888.3790
|
Wrist joint metal/polymer semi-constrained cemented prosthesis |
|
Section 888.3800
|
Wrist joint ulnar (hemi-wrist) polymer prosthesis |
|
Section 888.3810
|
Calipers for clinical use |
|
Section 888.4150
|
Cement dispenser |
|
Section 888.4200
|
Cement mixer for clinical use |
|
Section 888.4210
|
Cement monomer vapor evacuator |
|
Section 888.4220
|
Cement ventilation tube |
|
Section 888.4230
|
Depth gauge for clinical use |
|
Section 888.4300
|
Orthopedic manual surgical instrument |
|
Section 888.4540
|
Sonic surgical instrument and accessories/attachments |
|
Section 888.4580
|
Protractor for clinical use |
|
Section 888.4600
|
Template for clinical use |
|
Section 888.4800
|
Nonpowered orthopedic traction apparatus and accessories |
|
Section 888.5850
|
Noninvasive traction component |
|
Section 888.5890
|
Cast component |
|
Section 888.5940
|
Cast removal instrument |
|
Section 888.5960
|
Manual cast application and removal instrument |
|
Section 888.5980
|
Scope |