The following data is part of a premarket notification filed by Medacta International with the FDA for Masterloc Stem.
| Device ID | K151531 |
| 510k Number | K151531 |
| 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 Ch6874 |
| Contact | Michael G. Loiterman |
| Correspondent | Michael G. Loiterman MEDACTA USA 1556 W. CARROLL AVE. Chicago, IL 60607 |
| 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 | 2015-06-08 |
| Decision Date | 2015-10-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630030885723 | K151531 | 000 |
| 07630030885549 | K151531 | 000 |
| 07630030885556 | K151531 | 000 |
| 07630030885563 | K151531 | 000 |
| 07630030885570 | K151531 | 000 |
| 07630030885587 | K151531 | 000 |
| 07630030885594 | K151531 | 000 |
| 07630030885600 | K151531 | 000 |
| 07630030885617 | K151531 | 000 |
| 07630030885648 | K151531 | 000 |
| 07630030885655 | K151531 | 000 |
| 07630030885662 | K151531 | 000 |
| 07630030885679 | K151531 | 000 |
| 07630030885686 | K151531 | 000 |
| 07630030885693 | K151531 | 000 |
| 07630030885709 | K151531 | 000 |
| 07630030885716 | K151531 | 000 |
| 07630030885532 | K151531 | 000 |