FDA Product Code
FDA Product Code OOG — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3560
510(k) Clearances — 2 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K230850 | United Orthopedic Knee Patient Specific Instrumentation | Enhatch, Inc. | 2023-12-20 | Traditional | PDF ↗ |
| K203421 | Triathlon AS-1 | Conformis, Inc. | 2021-04-19 | Traditional | PDF ↗ |
Product code OOG · Class II · Orthopedic. Data: openFDA.