The following data is part of a premarket notification filed by Renovis Surgical Technologies with the FDA for Renovis Surgical Hip Replacement System.
| Device ID | K171543 |
| 510k Number | K171543 |
| Device Name: | Renovis Surgical Hip Replacement System |
| Classification | Hip Prosthesis, Semi-constrained, Cemented, Metal/polymer, + Additive, Porous, Uncemented |
| Applicant | Renovis Surgical Technologies 1901 W. Lugonia 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 | 2017-05-26 |
| Decision Date | 2017-11-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841523148332 | K171543 | 000 |
| 00841523133864 | K171543 | 000 |
| 00841523133871 | K171543 | 000 |
| 00841523133888 | K171543 | 000 |
| 00841523133895 | K171543 | 000 |
| 00841523133901 | K171543 | 000 |
| 00841523133918 | K171543 | 000 |
| 00841523133925 | K171543 | 000 |
| 00841523133932 | K171543 | 000 |
| 00841523133949 | K171543 | 000 |
| 00841523133956 | K171543 | 000 |
| 00841523148301 | K171543 | 000 |
| 00841523148318 | K171543 | 000 |
| 00841523148325 | K171543 | 000 |
| 00841523133857 | K171543 | 000 |