FDA Product Code
FDA Product Code NJD — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3535
510(k) Clearances — 5 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K251975 | Achieve Partial Knee System - Porous Coated CoCrMo Femoral Component | Ignite Orthomotion | 2025-09-02 | Traditional | PDF ↗ |
| K242307 | ACHIEVE Partial Knee System | Ignite Orthomotion | 2024-12-16 | Traditional | PDF ↗ |
| K222653 | JOURNEY II UK and ENGAGE Cementless Partial Knee System | Smith+Nephew, Inc. | 2022-10-28 | Traditional | PDF ↗ |
| K190439 | Engage Partial Knee System | Engage Uni, LLC | 2019-11-21 | Traditional | PDF ↗ |
| K133811 | RESTORIS POROUS PARTIAL KNEE SYSTEM | Mako Surgical Corp. | 2014-07-08 | Traditional | PDF ↗ |
Product code NJD · Class II · Orthopedic. Data: openFDA.