The following data is part of a premarket notification filed by Medacta International Sa with the FDA for Quadra P.
| Device ID | K181254 |
| 510k Number | K181254 |
| Device Name: | Quadra P |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | Medacta International SA Strada Regina Castel San Pietro, CH Ch-6874 |
| Contact | Stefano Baj |
| Correspondent | Chris Lussier Medacta USA 3973 Delp Street Memphis, TN 38118 |
| Product Code | LZO |
| Subsequent Product Code | KWY |
| Subsequent Product Code | LPH |
| Subsequent Product Code | LZY |
| Subsequent Product Code | MEH |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-11 |
| Decision Date | 2018-10-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630040727747 | K181254 | 000 |
| 07630040720502 | K181254 | 000 |
| 07630040720496 | K181254 | 000 |
| 07630040720489 | K181254 | 000 |
| 07630040720472 | K181254 | 000 |
| 07630040720465 | K181254 | 000 |
| 07630040720458 | K181254 | 000 |
| 07630040720441 | K181254 | 000 |
| 07630040720434 | K181254 | 000 |
| 07630040720427 | K181254 | 000 |
| 07630040720519 | K181254 | 000 |
| 07630040720526 | K181254 | 000 |
| 07630040727730 | K181254 | 000 |
| 07630040720601 | K181254 | 000 |
| 07630040720595 | K181254 | 000 |
| 07630040720588 | K181254 | 000 |
| 07630040720571 | K181254 | 000 |
| 07630040720564 | K181254 | 000 |
| 07630040720557 | K181254 | 000 |
| 07630040720540 | K181254 | 000 |
| 07630040720533 | K181254 | 000 |
| 07630040720410 | K181254 | 000 |