The following data is part of a premarket notification filed by Medacta International, Sa with the FDA for Medacta Total Hip Prosthesis System - Quadra C.
| Device ID | K083558 |
| 510k Number | K083558 |
| Device Name: | MEDACTA TOTAL HIP PROSTHESIS SYSTEM - QUADRA C |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| 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 | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-02 |
| Decision Date | 2009-03-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630030802362 | K083558 | 000 |
| 07630030802225 | K083558 | 000 |
| 07630030802232 | K083558 | 000 |
| 07630030802249 | K083558 | 000 |
| 07630030802256 | K083558 | 000 |
| 07630030802263 | K083558 | 000 |
| 07630030802270 | K083558 | 000 |
| 07630030802287 | K083558 | 000 |
| 07630030802300 | K083558 | 000 |
| 07630030802317 | K083558 | 000 |
| 07630030802324 | K083558 | 000 |
| 07630030802331 | K083558 | 000 |
| 07630030802348 | K083558 | 000 |
| 07630030802355 | K083558 | 000 |
| 07630030802218 | K083558 | 000 |