The following data is part of a premarket notification filed by Limacorporate S.p.a. with the FDA for H-max S Femoral Hip System.
| Device ID | K150855 |
| 510k Number | K150855 |
| Device Name: | H-MAX S Femoral Hip System |
| Classification | Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate |
| Applicant | Limacorporate S.P.A. Via Nazionale, 52 Villanova Di San Daniele, IT 33038 |
| Contact | Sara Viel |
| Correspondent | Stephen J Peoples Limacorporate S.P.A. Via Nazionale, 52 Villanova Di San Daniele, IT 33038 |
| Product Code | MEH |
| Subsequent Product Code | JDI |
| Subsequent Product Code | KWY |
| Subsequent Product Code | LPH |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-31 |
| Decision Date | 2015-10-21 |
| Summary: | summary |