The following data is part of a premarket notification filed by Limacorporate S.p.a. with the FDA for Smr 40mm Glenosphere.
| Device ID | K142139 |
| 510k Number | K142139 |
| Device Name: | SMR 40MM GLENOSPHERE |
| Classification | Shoulder Prosthesis, Reverse Configuration |
| 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 | PHX |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-05 |
| Decision Date | 2014-11-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08033390103428 | K142139 | 000 |
| 08033390103411 | K142139 | 000 |
| 08033390103404 | K142139 | 000 |
| 08033390103398 | K142139 | 000 |
| 08033390103381 | K142139 | 000 |
| 08033390103374 | K142139 | 000 |
| 08033390103442 | K142139 | 000 |