The following data is part of a premarket notification filed by Interbody Innovations Llp with the FDA for Interbody Innovations Cement Restrictor.
| Device ID | K051371 |
| 510k Number | K051371 |
| Device Name: | INTERBODY INNOVATIONS CEMENT RESTRICTOR |
| Classification | Prosthesis, Hip, Cement Restrictor |
| Applicant | INTERBODY INNOVATIONS LLP 2454 MCMULLEN BOOTH RD. SUITE 427 Clearwater, FL 33759 |
| Contact | Ian Gordon |
| Correspondent | Ian Gordon INTERBODY INNOVATIONS LLP 2454 MCMULLEN BOOTH RD. SUITE 427 Clearwater, FL 33759 |
| Product Code | JDK |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-05-26 |
| Decision Date | 2005-12-06 |
| Summary: | summary |