The following data is part of a premarket notification filed by Renovis Surgical Technologies, Inc. with the FDA for Renovis Surgical Porous Acetabular Cup System.
| Device ID | K141676 |
| 510k Number | K141676 |
| Device Name: | RENOVIS SURGICAL POROUS ACETABULAR CUP SYSTEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | Renovis Surgical Technologies, Inc. 200 HOMER AVE. Ashland, MA 01721 |
| Contact | Sharyn Orton, Ph.d. |
| Correspondent | Sharyn Orton, Ph.d. Renovis Surgical Technologies, Inc. 200 HOMER AVE. Ashland, MA 01721 |
| Product Code | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-06-23 |
| Decision Date | 2014-11-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841523106462 | K141676 | 000 |
| 00841523106332 | K141676 | 000 |
| 00841523106325 | K141676 | 000 |
| 00841523106318 | K141676 | 000 |
| 00841523106301 | K141676 | 000 |
| 00841523106295 | K141676 | 000 |
| 00841523106288 | K141676 | 000 |
| 00841523106271 | K141676 | 000 |
| 00841523106264 | K141676 | 000 |
| 00841523106240 | K141676 | 000 |
| 00841523106349 | K141676 | 000 |
| 00841523106356 | K141676 | 000 |
| 00841523106363 | K141676 | 000 |
| 00841523106455 | K141676 | 000 |
| 00841523106448 | K141676 | 000 |
| 00841523106431 | K141676 | 000 |
| 00841523106424 | K141676 | 000 |
| 00841523106417 | K141676 | 000 |
| 00841523106400 | K141676 | 000 |
| 00841523106394 | K141676 | 000 |
| 00841523106387 | K141676 | 000 |
| 00841523106370 | K141676 | 000 |
| 00841523106233 | K141676 | 000 |