The following data is part of a premarket notification filed by Limacorporate S.p.a. with the FDA for H-max S Stem.
| Device ID | K160011 |
| 510k Number | K160011 |
| Device Name: | H-Max S Stem |
| 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 | Emanuele Buttazzoni |
| Correspondent | Stephen Peoples PEOPLES & ASSOCIATES - STEPHEN J. PEOPLES, VMD, MS 411 AUDITORIUM BLVD. Winona Lake, IN 46590 |
| Product Code | MEH |
| Subsequent Product Code | JDI |
| Subsequent Product Code | KWY |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-01-04 |
| Decision Date | 2016-08-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08033390299961 | K160011 | 000 |
| 08033390298957 | K160011 | 000 |
| 08033390298940 | K160011 | 000 |
| 08033390298933 | K160011 | 000 |
| 08033390298926 | K160011 | 000 |
| 08033390298919 | K160011 | 000 |
| 08033390298902 | K160011 | 000 |
| 08033390298896 | K160011 | 000 |
| 08033390298889 | K160011 | 000 |
| 08033390269162 | K160011 | 000 |
| 08033390298964 | K160011 | 000 |
| 08033390298971 | K160011 | 000 |
| 08033390299954 | K160011 | 000 |
| 08033390299947 | K160011 | 000 |
| 08033390299930 | K160011 | 000 |
| 08033390299923 | K160011 | 000 |
| 08033390299916 | K160011 | 000 |
| 08033390299909 | K160011 | 000 |
| 08033390299893 | K160011 | 000 |
| 08033390299886 | K160011 | 000 |
| 08033390299879 | K160011 | 000 |
| 08033390269155 | K160011 | 000 |