FDA Product Code
FDA Product Code HSH — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3590
510(k) Clearances — 5 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K073233 | ORTHOGLIDE LATERAL KNEE IMPLANT AND INSTRUMENTS | Advanced Bio-Surfaces, Inc. | 2008-01-28 | Traditional | PDF ↗ |
| K053094 | ORTHOGLIDE MEDICAL KNEE IMPLANT AND INSTRUMENTS, MODELS 9063, 9064, 9065, 9060, 9062, 9057, 9056 | Advanced Bio-Surfaces, Inc. | 2006-02-06 | Traditional | PDF ↗ |
| K033242 | KNEE INTERPOSITIONAL MINI-REPAIR SYSTEM (KIMRS) | Imaging Therapeutics, Inc. | 2003-12-31 | Traditional | PDF ↗ |
| K022779 | OTI UNICONDULAR INTERPOSITIONAL SPACER | Osteoimplant Technology, Inc. | 2002-11-20 | Traditional | PDF ↗ |
| K003269 | UNICONDYLAR INTERPOSITIONAL SPACER | Sulzer Orthopedics, Inc. | 2001-01-04 | Traditional | PDF ↗ |
Product code HSH · Class II · Orthopedic. Data: openFDA.