FDA Product Code
FDA Product Code KWP — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3050
510(k) Clearances — 430 records · page 5 of 5
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K882070 | LUMBAR IMPACTION SET AND BONE GRAFT IMPACTORS | Karlin Technology, Inc. | 1988-06-03 | Traditional | PDF ↗ |
| K882068 | COBB SPINAL ELEVATORS | Karlin Technology, Inc. | 1988-06-03 | Traditional | PDF ↗ |
| K880211 | TSRH H/M HOOK HOLDER | Warsaw Orthopedic, Inc. | 1988-03-04 | Traditional | PDF ↗ |
| K880212 | TSRH H/M HOOK HOLDER W/ROD MOVER | Warsaw Orthopedic, Inc. | 1988-03-04 | Traditional | PDF ↗ |
| K875290 | LUMBAR IMPACTION SET | T. Korossurgical Instruments Corp. | 1988-03-04 | Traditional | PDF ↗ |
| K880215 | TSRH H/M HOOK, EYEBOLT/LOCK NUT ASSEM., SPINAL ROD | Warsaw Orthopedic, Inc. | 1988-02-18 | Traditional | PDF ↗ |
| K874882 | ACROMED CROSS ROD CONNECTOR | Acromed Corp. | 1988-02-18 | Traditional | PDF ↗ |
| K880214 | TSRH H/M TORQUE LIMITING WRENCH | Warsaw Orthopedic, Inc. | 1988-02-18 | Traditional | PDF ↗ |
| K871870 | HSC UNIT ROD | Research Development Corp. | 1987-07-21 | Traditional | PDF ↗ |
| K870085 | ANTERIOR SPINAL FIXATION PLATE | Terray Manufacturing, Inc. | 1987-06-30 | Traditional | PDF ↗ |
| K870830 | WARSAW ORTHOPEDIC TSR CROSS LINK SYSTEM | Warsaw Orthopedic, Inc. | 1987-05-04 | Traditional | PDF ↗ |
| K854770 | MARTIN LAMINAR OSTEOSYNTHESIS SYSTEM | Advanced Biosearch Assn. | 1986-02-11 | Traditional | PDF ↗ |
| K854524 | KIRSCHNER SPINAL PRODUCT SYSTEM | Kirschner Medical Corp. | 1985-12-09 | Traditional | PDF ↗ |
| K854313 | SONGER TITANIUM SPINE-L-ROD | Ortho-Engineering Products Co. | 1985-11-15 | Traditional | PDF ↗ |
| K851935 | EDWARDS SACRAL SCREW | Zimmer, Inc. | 1985-06-07 | Traditional | PDF ↗ |
| K850039 | HALIFAX SPINAL CLAMP | Levtech, Inc. | 1985-05-29 | Traditional | PDF ↗ |
| K843445 | SACRAL BAR | Stuart | 1985-02-13 | Traditional | PDF ↗ |
| K843687 | ROD FOR RACHIS SURGERY | Sofamor Co. | 1985-01-10 | Traditional | PDF ↗ |
| K840423 | HARRINGTON-TYPE INSTRU-SCOLIOSIS | Link America, Inc. | 1984-03-23 | Traditional | PDF ↗ |
| K820660 | A HOOK DRIVER | Twin City Surgical, Inc. | 1982-03-19 | Traditional | PDF ↗ |
| K810329 | DEPUY SEGMENTALSPINAL SYSTEM | Depuy, Inc. | 1981-04-08 | Traditional | PDF ↗ |
| K810224 | ARMSTRONG SPINAL APPLIANCE | Howmedica Corp. | 1981-02-10 | Traditional | PDF ↗ |
| K802462 | SYNTHES SPINAL IMPLANT SYSTEM | Synthes (Usa) | 1980-12-16 | Traditional | PDF ↗ |
| K801080 | EDWARDS ROD SLEEVES | Zimmer, Inc. | 1980-05-20 | Traditional | PDF ↗ |
| K801120 | DUNN ANTERIOR DISTRACTION SYSTEM | Zimmer, Inc. | 1980-05-20 | Traditional | PDF ↗ |
| K791009 | SANTA CASA DISTRACTOR | Depuy, Inc. | 1979-06-11 | Traditional | PDF ↗ |
| K790465 | KNEE COMPRESSION HOOK SYSTEM | Zimmer, Inc. | 1979-04-12 | Traditional | PDF ↗ |
| K790238 | TRANSVERSE TRACTION ASSEMBLY | Zimmer, Inc. | 1979-02-12 | Traditional | PDF ↗ |
| K781443 | HARRINGTON SPINE INSTRUMENTATION | Orthopedic Equipment Co., Inc. | 1978-09-27 | Traditional | PDF ↗ |
| K781444 | OUTRIGGER DISTRACTION UNIT | Orthopedic Equipment Co., Inc. | 1978-09-27 | Traditional | PDF ↗ |
Product code KWP · Class II · Orthopedic. Data: openFDA.