Federal (United States) · Regulations
Subpart D — Prosthetic Devices
76 sections
76 sections
- 21 C.F.R. § 888.3000Bone cap.
- 21 C.F.R. § 888.3010Bone fixation cerclage.
- 21 C.F.R. § 888.3015Bone heterograft.
- 21 C.F.R. § 888.3020Intramedullary fixation rod.
- 21 C.F.R. § 888.3023In vivo cured intramedullary fixation rod.
- 21 C.F.R. § 888.3025Passive tendon prosthesis.
- 21 C.F.R. § 888.3027Polymethylmethacrylate (PMMA) bone cement.
- 21 C.F.R. § 888.3030Single/multiple component metallic bone fixation appliances and accessories.
- 21 C.F.R. § 888.3040Smooth or threaded metallic bone fixation fastener.
- 21 C.F.R. § 888.3043Screw sleeve bone fixation device.
- 21 C.F.R. § 888.3044Resorbable implant for anterior cruciate ligament (ACL) repair.
- 21 C.F.R. § 888.3045Resorbable calcium salt bone void filler device.
- 21 C.F.R. § 888.3050Spinal interlaminal fixation orthosis.
- 21 C.F.R. § 888.3060Spinal intervertebral body fixation orthosis.
- 21 C.F.R. § 888.3070Thoracolumbosacral pedicle screw system.
- 21 C.F.R. § 888.3075Posterior cervical screw system.
- 21 C.F.R. § 888.3080Intervertebral body fusion device.
- 21 C.F.R. § 888.3083Spinal spheres for use in intervertebral fusion procedures.
- 21 C.F.R. § 888.3085Intervertebral body graft containment device.
- 21 C.F.R. § 888.3090Intraoperative orthopedic strain sensor.
- 21 C.F.R. § 888.3100Ankle joint metal/composite semi-constrained cemented prosthesis.
- 21 C.F.R. § 888.3110Ankle joint metal/polymer semi-constrained cemented prosthesis.
- 21 C.F.R. § 888.3120Ankle joint metal/polymer non-constrained cemented prosthesis.
- 21 C.F.R. § 888.3150Elbow joint metal/polymer constrained cemented prosthesis.
- 21 C.F.R. § 888.3160Elbow joint metal/polymer semi-constrained cemented prosthesis.
- 21 C.F.R. § 888.3170Elbow joint radial (hemi-elbow) polymer prosthesis.
- 21 C.F.R. § 888.3180Elbow joint humeral (hemi-elbow) metallic uncemented prosthesis.
- 21 C.F.R. § 888.3200Finger joint metal/metal constrained uncemented prosthesis.
- 21 C.F.R. § 888.3210Finger joint metal/metal constrained cemented prosthesis.
- 21 C.F.R. § 888.3220Finger joint metal/polymer constrained cemented prosthesis.
- 21 C.F.R. § 888.3230Finger joint polymer constrained prosthesis.
- 21 C.F.R. § 888.3300Hip joint metal constrained cemented or uncemented prosthesis.
- 21 C.F.R. § 888.3310Hip joint metal/polymer constrained cemented or uncemented prosthesis.
- 21 C.F.R. § 888.3320Hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis.
- 21 C.F.R. § 888.3330Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.
- 21 C.F.R. § 888.3340Hip joint metal/composite semi-constrained cemented prosthesis.
- 21 C.F.R. § 888.3350Hip joint metal/polymer semi-constrained cemented prosthesis.
- 21 C.F.R. § 888.3353Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
- 21 C.F.R. § 888.3358Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
- 21 C.F.R. § 888.3360Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.
- 21 C.F.R. § 888.3370Hip joint (hemi-hip) acetabular metal cemented prosthesis.
- 21 C.F.R. § 888.3380Hip joint femoral (hemi-hip) trunnion-bearing metal/polyacetal cemented prosthesis.
- 21 C.F.R. § 888.3390Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis.
- 21 C.F.R. § 888.3400Hip joint femoral (hemi-hip) metallic resurfacing prosthesis.
- 21 C.F.R. § 888.3410Hip joint metal/polymer or ceramic/polymer semiconstrained resurfacing cemented prosthesis.
- 21 C.F.R. § 888.3480Knee joint femorotibial metallic constrained cemented prosthesis.
- 21 C.F.R. § 888.3490Knee joint femorotibial metal/composite non-constrained cemented prosthesis.
- 21 C.F.R. § 888.3500Knee joint femorotibial metal/composite semi-constrained cemented prosthesis.
- 21 C.F.R. § 888.3510Knee joint femorotibial metal/polymer constrained cemented prosthesis.
- 21 C.F.R. § 888.3520Knee joint femorotibial metal/polymer non-constrained cemented prosthesis.
- 21 C.F.R. § 888.3530Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis.
- 21 C.F.R. § 888.3535Knee joint femorotibial (uni-compartmental) metal/polymer porous-coated uncemented prosthesis.
- 21 C.F.R. § 888.3540Knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis.
- 21 C.F.R. § 888.3550Knee joint patellofemorotibial polymer/metal/metal constrained cemented prosthesis.
- 21 C.F.R. § 888.3560Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
- 21 C.F.R. § 888.3565Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.
- 21 C.F.R. § 888.3570Knee joint femoral (hemi-knee) metallic uncemented prosthesis.
- 21 C.F.R. § 888.3580Knee joint patellar (hemi-knee) metallic resurfacing uncemented prosthesis.
- 21 C.F.R. § 888.3590Knee joint tibial (hemi-knee) metallic resurfacing uncemented prosthesis.
- 21 C.F.R. § 888.3600Implantable post-surgical kinematic measurement knee device.
- 21 C.F.R. § 888.3630Resorbable shoulder spacer.
- 21 C.F.R. § 888.3640Shoulder joint metal/metal or metal/polymer constrained cemented prosthesis.
- 21 C.F.R. § 888.3650Shoulder joint metal/polymer non-constrained cemented prosthesis.
- 21 C.F.R. § 888.3660Shoulder joint metal/polymer semi-constrained cemented prosthesis.
- 21 C.F.R. § 888.3670Shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis.
- 21 C.F.R. § 888.3680Shoulder joint glenoid (hemi-shoulder) metallic cemented prosthesis.
- 21 C.F.R. § 888.3690Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis.
- 21 C.F.R. § 888.3720Toe joint polymer constrained prosthesis.
- 21 C.F.R. § 888.3730Toe joint phalangeal (hemi-toe) polymer prosthesis.
- 21 C.F.R. § 888.3750Wrist joint carpal lunate polymer prosthesis.
- 21 C.F.R. § 888.3760Wrist joint carpal scaphoid polymer prosthesis.
- 21 C.F.R. § 888.3770Wrist joint carpal trapezium polymer prosthesis.
- 21 C.F.R. § 888.3780Wrist joint polymer constrained prosthesis.
- 21 C.F.R. § 888.3790Wrist joint metal constrained cemented prosthesis.
- 21 C.F.R. § 888.3800Wrist joint metal/polymer semi-constrained cemented prosthesis.
- 21 C.F.R. § 888.3810Wrist joint ulnar (hemi-wrist) polymer prosthesis.