The following data is part of a premarket notification filed by Renovis Surgical Technologies, Inc. with the FDA for Renovis Surgical Hip Replacement System.
| Device ID | K143647 |
| 510k Number | K143647 |
| Device Name: | Renovis Surgical Hip Replacement System |
| Classification | Hip Prosthesis, Semi-constrained, Cemented, Metal/polymer, + Additive, Porous, Uncemented |
| Applicant | Renovis Surgical Technologies, Inc. 1901 W. Lugonia Ave, Suite 340 Redlands, CA 92374 |
| Contact | Anthony Debenedictis |
| Correspondent | Sharyn Orton MEDIcept. Inc. 200 Homer Ave Ashland, MA 01721 |
| Product Code | OQG |
| Subsequent Product Code | LPH |
| Subsequent Product Code | LZO |
| Subsequent Product Code | OQI |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-22 |
| Decision Date | 2015-05-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841523105861 | K143647 | 000 |
| 00841523105854 | K143647 | 000 |
| 00841523105847 | K143647 | 000 |
| 00841523105830 | K143647 | 000 |