The following data is part of a premarket notification filed by Medacta International, Sa with the FDA for Total Hip Prosthesis System Quadra S + Cocrmo Femoral Ball Head + Apricot.
| Device ID | K072857 |
| 510k Number | K072857 |
| Device Name: | TOTAL HIP PROSTHESIS SYSTEM QUADRA S + COCRMO FEMORAL BALL HEAD + APRICOT |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | MEDACTA INTERNATIONAL, SA 18 BIRDIE LANE Norfolk, MA 02056 |
| Contact | Pamela J Weagraff |
| Correspondent | Pamela J Weagraff MEDACTA INTERNATIONAL, SA 18 BIRDIE LANE Norfolk, MA 02056 |
| Product Code | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-10-05 |
| Decision Date | 2008-02-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630030805196 | K072857 | 000 |
| 07630030801969 | K072857 | 000 |
| 07630030801952 | K072857 | 000 |
| 07630030801945 | K072857 | 000 |
| 07630030801938 | K072857 | 000 |
| 07630030801921 | K072857 | 000 |
| 07630030801914 | K072857 | 000 |
| 07630030801907 | K072857 | 000 |
| 07630030801891 | K072857 | 000 |
| 07630030801884 | K072857 | 000 |
| 07630030801877 | K072857 | 000 |
| 07630030801860 | K072857 | 000 |
| 07630030801853 | K072857 | 000 |
| 07630030801846 | K072857 | 000 |
| 07630030801839 | K072857 | 000 |
| 07630030801822 | K072857 | 000 |
| 07630030801976 | K072857 | 000 |
| 07630030801983 | K072857 | 000 |
| 07630030801990 | K072857 | 000 |
| 07630030805189 | K072857 | 000 |
| 07630030805172 | K072857 | 000 |
| 07630030805165 | K072857 | 000 |
| 07630030805158 | K072857 | 000 |
| 07630030805141 | K072857 | 000 |
| 07630030805134 | K072857 | 000 |
| 07630030805127 | K072857 | 000 |
| 07630030805110 | K072857 | 000 |
| 07630030805103 | K072857 | 000 |
| 07630030802553 | K072857 | 000 |
| 07630030802546 | K072857 | 000 |
| 07630030802539 | K072857 | 000 |
| 07630030802201 | K072857 | 000 |
| 07630030802119 | K072857 | 000 |
| 07630030802003 | K072857 | 000 |
| 07630030801815 | K072857 | 000 |