The following data is part of a premarket notification filed by Medacta International, Sa with the FDA for Medacta Total Hip Prosthesis System - Quadra H And R Femoral Stems.
| Device ID | K082792 |
| 510k Number | K082792 |
| Device Name: | MEDACTA TOTAL HIP PROSTHESIS SYSTEM - QUADRA H AND R FEMORAL STEMS |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| 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 | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-23 |
| Decision Date | 2008-12-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630030802737 | K082792 | 000 |
| 07630030802171 | K082792 | 000 |
| 07630030802164 | K082792 | 000 |
| 07630030802157 | K082792 | 000 |
| 07630030802140 | K082792 | 000 |
| 07630030802133 | K082792 | 000 |
| 07630030802126 | K082792 | 000 |
| 07630030802102 | K082792 | 000 |
| 07630030802096 | K082792 | 000 |
| 07630030802089 | K082792 | 000 |
| 07630030802072 | K082792 | 000 |
| 07630030802065 | K082792 | 000 |
| 07630030802058 | K082792 | 000 |
| 07630030802041 | K082792 | 000 |
| 07630030802034 | K082792 | 000 |
| 07630030802027 | K082792 | 000 |
| 07630030802188 | K082792 | 000 |
| 07630030802195 | K082792 | 000 |
| 07630030802386 | K082792 | 000 |
| 07630030802720 | K082792 | 000 |
| 07630030802713 | K082792 | 000 |
| 07630030802638 | K082792 | 000 |
| 07630030802621 | K082792 | 000 |
| 07630030802614 | K082792 | 000 |
| 07630030802607 | K082792 | 000 |
| 07630030802478 | K082792 | 000 |
| 07630030802461 | K082792 | 000 |
| 07630030802454 | K082792 | 000 |
| 07630030802447 | K082792 | 000 |
| 07630030802430 | K082792 | 000 |
| 07630030802423 | K082792 | 000 |
| 07630030802416 | K082792 | 000 |
| 07630030802409 | K082792 | 000 |
| 07630030802393 | K082792 | 000 |
| 07630030802010 | K082792 | 000 |