The following data is part of a premarket notification filed by Medacta International, Sa with the FDA for Mpres Neck Preserving Stem.
| Device ID | K210263 |
| 510k Number | K210263 |
| Device Name: | Mpres Neck Preserving Stem |
| 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 83118 |
| Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-01 |
| Decision Date | 2021-09-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630345713605 | K210263 | 000 |
| 07630345713452 | K210263 | 000 |
| 07630345713445 | K210263 | 000 |
| 07630345713438 | K210263 | 000 |
| 07630345713421 | K210263 | 000 |
| 07630345713414 | K210263 | 000 |
| 07630345713407 | K210263 | 000 |
| 07630345713391 | K210263 | 000 |
| 07630345713384 | K210263 | 000 |
| 07630345713377 | K210263 | 000 |
| 07630345713360 | K210263 | 000 |
| 07630345713469 | K210263 | 000 |
| 07630345713490 | K210263 | 000 |
| 07630345713599 | K210263 | 000 |
| 07630345713582 | K210263 | 000 |
| 07630345713575 | K210263 | 000 |
| 07630345713568 | K210263 | 000 |
| 07630345713551 | K210263 | 000 |
| 07630345713544 | K210263 | 000 |
| 07630345713537 | K210263 | 000 |
| 07630345713520 | K210263 | 000 |
| 07630345713513 | K210263 | 000 |
| 07630345713506 | K210263 | 000 |
| 07630345713353 | K210263 | 000 |