The following data is part of a premarket notification filed by Renovis Surgical Technologies, Inc. with the FDA for Renovis Cemented Hip System.
| Device ID | K141370 |
| 510k Number | K141370 |
| Device Name: | RENOVIS CEMENTED HIP SYSTEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | Renovis Surgical Technologies, Inc. 200 HOMER AVE. Ashland, MA 01721 |
| Contact | Sharyn Orton |
| Correspondent | Sharyn Orton Renovis Surgical Technologies, Inc. 200 HOMER AVE. Ashland, MA 01721 |
| Product Code | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-27 |
| Decision Date | 2014-09-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841523105687 | K141370 | 000 |
| 00841523105700 | K141370 | 000 |
| 00841523105717 | K141370 | 000 |
| 00841523105724 | K141370 | 000 |
| 00841523105731 | K141370 | 000 |
| 00841523105748 | K141370 | 000 |
| 00841523105793 | K141370 | 000 |
| 00841523105816 | K141370 | 000 |
| 00841523105823 | K141370 | 000 |
| 00841523105670 | K141370 | 000 |
| 00841523105694 | K141370 | 000 |
| 00841523105762 | K141370 | 000 |
| 00841523105779 | K141370 | 000 |
| 00841523105786 | K141370 | 000 |
| 00841523105663 | K141370 | 000 |
| 00841523105755 | K141370 | 000 |
| 00841523105809 | K141370 | 000 |
| 00841523105656 | K141370 | 000 |