The following data is part of a premarket notification filed by Medacta International, Sa with the FDA for Medacta Bone Screws - Evolis And Versafit.
| Device ID | K091069 |
| 510k Number | K091069 |
| Device Name: | MEDACTA BONE SCREWS - EVOLIS AND VERSAFIT |
| Classification | Screw, Fixation, Bone |
| Applicant | MEDACTA INTERNATIONAL, SA 13721 VIA TRES VISTA San Diego, CA 92129 |
| Contact | Natalie J Kennel |
| Correspondent | Natalie J Kennel MEDACTA INTERNATIONAL, SA 13721 VIA TRES VISTA San Diego, CA 92129 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-14 |
| Decision Date | 2009-06-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630030846649 | K091069 | 000 |
| 07630030846632 | K091069 | 000 |
| 07630030846625 | K091069 | 000 |
| 07630030846618 | K091069 | 000 |
| 07630030846601 | K091069 | 000 |
| 07630030846595 | K091069 | 000 |