The following data is part of a premarket notification filed by Medacta International Sa with the FDA for Masterloc Stem: Lateralized Plus.
| Device ID | K173267 |
| 510k Number | K173267 |
| Device Name: | MasterLoc Stem: Lateralized Plus |
| 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 | Elizabeth Rose 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 | 2017-10-11 |
| Decision Date | 2017-12-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630040715843 | K173267 | 000 |
| 07630040715836 | K173267 | 000 |
| 07630040715829 | K173267 | 000 |
| 07630040715812 | K173267 | 000 |
| 07630040715805 | K173267 | 000 |
| 07630040715799 | K173267 | 000 |
| 07630040715782 | K173267 | 000 |
| 07630040715775 | K173267 | 000 |
| 07630040715768 | K173267 | 000 |