The following data is part of a premarket notification filed by Limacorporate S.p.a. with the FDA for Minima S System.
| Device ID | K141327 |
| 510k Number | K141327 |
| Device Name: | MINIMA S SYSTEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | LIMACORPORATE S.P.A. 5010 LODGE POLE LANE Fort Wayne, IN 46814 |
| Contact | Stephen 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 |
| Subsequent Product Code | MBL |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-21 |
| Decision Date | 2014-08-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08033390085274 | K141327 | 000 |
| 08033390007191 | K141327 | 000 |
| 08033390007184 | K141327 | 000 |
| 08033390007177 | K141327 | 000 |
| 08033390090827 | K141327 | 000 |
| 08033390090810 | K141327 | 000 |
| 08033390090803 | K141327 | 000 |
| 08033390090797 | K141327 | 000 |
| 08033390090780 | K141327 | 000 |
| 08033390090773 | K141327 | 000 |
| 08033390090766 | K141327 | 000 |
| 08033390090759 | K141327 | 000 |
| 08033390090742 | K141327 | 000 |
| 08033390083935 | K141327 | 000 |
| 08033390083331 | K141327 | 000 |
| 08033390083324 | K141327 | 000 |
| 08033390007207 | K141327 | 000 |
| 08033390007214 | K141327 | 000 |
| 08033390007221 | K141327 | 000 |
| 08033390083348 | K141327 | 000 |
| 08033390084987 | K141327 | 000 |
| 08033390084970 | K141327 | 000 |
| 08033051091569 | K141327 | 000 |
| 08033390179317 | K141327 | 000 |
| 08033390153973 | K141327 | 000 |
| 08033390153966 | K141327 | 000 |
| 08033390153959 | K141327 | 000 |
| 08033390153942 | K141327 | 000 |
| 08033390153935 | K141327 | 000 |
| 08033390153928 | K141327 | 000 |
| 08033390007269 | K141327 | 000 |
| 08033390007252 | K141327 | 000 |
| 08033390007245 | K141327 | 000 |
| 08033390007238 | K141327 | 000 |
| 08033390083317 | K141327 | 000 |