The following data is part of a premarket notification filed by Medacta International with the FDA for Masterloc Stem.
| Device ID | K160289 |
| 510k Number | K160289 |
| Device Name: | MasterLoc Stem |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | MEDACTA INTERNATIONAL STRADA REGINA Castel San Pietro, CH Ch 6874 |
| Contact | Michael G. Loiterman |
| Correspondent | Roshana Ahmed Mapi USA, Inc. 2343 Alexandria Drive, Suite 100 Lexington, KY 40504 |
| 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 | 2016-02-03 |
| Decision Date | 2016-05-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630030885631 | K160289 | 000 |
| 07630030885624 | K160289 | 000 |
| 07630030885525 | K160289 | 000 |
| 07630030885518 | K160289 | 000 |
| 07630030861284 | K160289 | 000 |
| 07630030861260 | K160289 | 000 |