HSH — Prosthesis, Knee, Hemi-, Tibial, Resurfacing (Uncemented) Class II
FDA product code HSH covers "Prosthesis, Knee, Hemi-, Tibial, Resurfacing (Uncemented)", a Class II medical device regulated under 21 CFR 888.3590. Submissions are reviewed by the Orthopedic panel. Devices under this code are implants. At least 5 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- HSH
- Device Class
- Class II
- Regulation Number
- 888.3590
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K073233 | advanced bio-surfaces | ORTHOGLIDE LATERAL KNEE IMPLANT AND INSTRUMENTS | January 28, 2008 |
| K053094 | advanced bio-surfaces | ORTHOGLIDE MEDICAL KNEE IMPLANT AND INSTRUMENTS, MODELS 9063, 9064, 9065, 9060, | February 6, 2006 |
| K033242 | imaging therapeutics | KNEE INTERPOSITIONAL MINI-REPAIR SYSTEM (KIMRS) | December 31, 2003 |
| K022779 | osteoimplant technology | OTI UNICONDULAR INTERPOSITIONAL SPACER | November 20, 2002 |
| K003269 | sulzer orthopedics | UNICONDYLAR INTERPOSITIONAL SPACER | January 4, 2001 |