The following data is part of a premarket notification filed by Limacorporate S.p.a. with the FDA for Mastersl Femoral Stem.
| Device ID | K143509 |
| 510k Number | K143509 |
| Device Name: | MasterSL Femoral Stem |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | LIMACORPORATE S.P.A. VIA NAZIONALE, 52 Villanova Di San Daniele, IT 33038 |
| Contact | Stephen J Peoples |
| Correspondent | Stephen Peoples LIMACORPORATE S.P.A. 5010 Lodge Pole Lane Fort Wayne, IN 46814 |
| Product Code | LZO |
| Subsequent Product Code | JDI |
| Subsequent Product Code | KWY |
| Subsequent Product Code | KWZ |
| Subsequent Product Code | LPH |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-11 |
| Decision Date | 2015-01-27 |
| Summary: | summary |