The following data is part of a premarket notification filed by Renovis Surgical Technologies Llc with the FDA for Renovis Bipolar Hip System.
| Device ID | K131354 |
| 510k Number | K131354 |
| Device Name: | RENOVIS BIPOLAR HIP SYSTEM |
| Classification | Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented |
| Applicant | RENOVIS SURGICAL TECHNOLOGIES LLC 200 HOMER AVE Ashland, MA 0172- 0000 |
| Contact | Sharyn Orton |
| Correspondent | Sharyn Orton RENOVIS SURGICAL TECHNOLOGIES LLC 200 HOMER AVE Ashland, MA 0172- 0000 |
| Product Code | KWY |
| CFR Regulation Number | 888.3390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-10 |
| Decision Date | 2013-09-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841523105557 | K131354 | 000 |
| 00841523105519 | K131354 | 000 |
| 00841523105472 | K131354 | 000 |
| 00841523105465 | K131354 | 000 |
| 00841523105458 | K131354 | 000 |
| 00841523105441 | K131354 | 000 |
| 00841523105434 | K131354 | 000 |
| 00841523105427 | K131354 | 000 |
| 00841523105410 | K131354 | 000 |
| 00841523105403 | K131354 | 000 |
| 00841523105397 | K131354 | 000 |
| 00841523105380 | K131354 | 000 |
| 00841523105373 | K131354 | 000 |
| 00841523105366 | K131354 | 000 |
| 00841523105533 | K131354 | 000 |
| 00841523105595 | K131354 | 000 |
| 00841523105540 | K131354 | 000 |
| 00841523105489 | K131354 | 000 |
| 00841523105588 | K131354 | 000 |
| 00841523105571 | K131354 | 000 |
| 00841523105564 | K131354 | 000 |
| 00841523105526 | K131354 | 000 |
| 00841523105502 | K131354 | 000 |
| 00841523105496 | K131354 | 000 |
| 00841523105649 | K131354 | 000 |
| 00841523105632 | K131354 | 000 |
| 00841523105625 | K131354 | 000 |
| 00841523105618 | K131354 | 000 |
| 00841523105601 | K131354 | 000 |
| 00841523105359 | K131354 | 000 |