Part 888 Subpart E—Surgical Devices
FDA submissions for Part 888 Subpart E—Surgical Devices in the Orthopedic (OR) review panel, including product codes and regulations.
Section range: §§ 888.4150–888.5980
CFR Part: 888
Product Codes
| Product Code | Device Name | Regulation | Class | Devices |
|---|---|---|---|---|
| KTZ | Caliper | 888.4150 | 1 | 7 |
| KIH | Dispenser, Cement | 888.4200 | 1 | 11 |
| OAR | Injector, Vertebroplasty (Does Not Contain Cement) | 888.4200 | 1 | 1 |
| JDZ | Mixer, Cement, For Clinical Use | 888.4210 | 1 | 13 |
| JDY | Evacuator, Vapor, Cement Monomer | 888.4220 | 1 | 8 |
| KII | Tube, Cement Ventilation | 888.4230 | 1 | 0 |
| HTJ | Gauge, Depth | 888.4300 | 1 | 4 |
| QBO | Instruments Designed For Press-Fit Osteochondral Implants | 888.4505 | 2 | 2 |
| QHG | Defect Measurement Tool | 888.4510 | 2 | 1 |
| QLQ | Manual Instruments Designed For Use With Total Disc Replacement Devices | 888.4515 | 2 | 8 |
| QLR | Manual Instruments Designed For Use With Non-Fusion Spinous Process Spacer Devices | 888.4520 | 2 | 1 |
| HRR | Scissors, Orthopedic, Surgical | 888.4540 | 1 | 8 |
| HRT | Stripper, Surgical | 888.4540 | 1 | 0 |
| HTO | Reamer | 888.4540 | 1 | 14 |
| HTP | File | 888.4540 | 1 | 5 |
| HTQ | Broach | 888.4540 | 1 | 0 |
| HTS | Knife, Orthopedic | 888.4540 | 1 | 9 |
| HTT | Burr, Orthopedic | 888.4540 | 1 | 4 |
| HTW | Bit, Drill | 888.4540 | 1 | 11 |
| HTX | Rongeur | 888.4540 | 1 | 5 |
| HWA | Impactor | 888.4540 | 1 | 4 |
| HWB | Extractor | 888.4540 | 1 | 5 |
| HWD | Starter, Bone Screw | 888.4540 | 1 | 0 |
| HWI | Corkscrew | 888.4540 | 1 | 1 |
| HWJ | Awl | 888.4540 | 1 | 4 |
| HWK | Trephine | 888.4540 | 1 | 1 |
| HWL | Set, Hollow Mill | 888.4540 | 1 | 0 |
| HWN | Instrument, Compression | 888.4540 | 1 | 4 |
| HWO | Skid, Bone | 888.4540 | 1 | 0 |
| HWP | Punch, Femoral Neck | 888.4540 | 1 | 1 |
| HWQ | Passer | 888.4540 | 1 | 9 |
| HWR | Driver, Prosthesis | 888.4540 | 1 | 4 |
| HWW | Countersink | 888.4540 | 1 | 0 |
| HWX | Tap, Bone | 888.4540 | 1 | 2 |
| HXB | Probe | 888.4540 | 1 | 15 |
| HXC | Wrench | 888.4540 | 1 | 6 |
| HXE | Fork | 888.4540 | 1 | 0 |
| HXG | Tamp | 888.4540 | 1 | 1 |
| HXI | Passer, Wire, Orthopedic | 888.4540 | 1 | 3 |
| HXJ | Staple Driver | 888.4540 | 1 | 6 |
| HXK | Holder, Needle; Orthopedic | 888.4540 | 1 | 5 |
| HXN | Applier, Cerclage | 888.4540 | 1 | 2 |
| HXO | Pusher, Socket | 888.4540 | 1 | 3 |
| HXP | Instrument, Bending Or Contouring | 888.4540 | 1 | 5 |
| HXQ | Crimper, Pin | 888.4540 | 1 | 0 |
| HXS | Twister, Wire | 888.4540 | 1 | 2 |
| HXW | Bender | 888.4540 | 1 | 3 |
| HXX | Screwdriver | 888.4540 | 1 | 4 |
| HXY | Brace, Drill | 888.4540 | 1 | 7 |
| HXZ | Cutter, Wire | 888.4540 | 1 | 1 |
| KIL | Positioner, Socket | 888.4540 | 1 | 1 |
| LXH | Orthopedic Manual Surgical Instrument | 888.4540 | 1 | 58 |
| LYQ | Accessories, Fixation, Spinal Intervertebral Body | 888.4540 | 1 | 3 |
| LYS | Bone Mill | 888.4540 | 1 | 4 |
| OCJ | Spinal Channeling Instrument, Vertebroplasty | 888.4540 | 1 | 1 |
| QWL | Intraoperative Surgical Angle Measurement Tool | 888.4560 | 2 | 3 |
| JDX | Instrument, Surgical, Sonic And Accessory/Attachment | 888.4580 | 2 | 23 |
| LZV | System, Cement Removal Extraction | 888.4580 | 2 | 7 |
| HTH | Protractor | 888.4600 | 1 | 3 |
| HWT | Template | 888.4800 | 1 | 10 |
| HST | Apparatus, Traction, Non-Powered | 888.5850 | 1 | 38 |
| HSP | Splint, Traction | 888.5890 | 1 | 1 |
| HSQ | Belt, Pelvic, Traction | 888.5890 | 1 | 1 |
| HSR | Unit, Traction, Hip, Non-Powered, Non-Penetrating | 888.5890 | 1 | 1 |
| HSS | Halter, Head, Traction | 888.5890 | 1 | 3 |
| KQZ | Component, Traction, Non-Invasive | 888.5890 | 1 | 11 |
| QZO | Wearable Vibration Device For Orthopedic Use | 888.5895 | 2 | 1 |
| LGF | Component, Cast | 888.5940 | 1 | 31 |
| LGH | Instrument, Cast Removal, Ac-Powered | 888.5960 | 1 | 9 |
| LGG | Instrument, Cast Application/Removal, Manual | 888.5980 | 1 | 3 |
