The following data is part of a premarket notification filed by Limacorporate S.p.a. with the FDA for Smr Modular Glenoid.
| Device ID | K143256 |
| 510k Number | K143256 |
| Device Name: | SMR Modular Glenoid |
| Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented |
| Applicant | Limacorporate S.P.A. Via Nazionale, 52 Villanova Di San Daniele, IT 33038 |
| Contact | Stephen J. Peoples |
| Correspondent | Stephen J. Peoples Limacorporate S.P.A. Via Nazionale, 52 Villanova Di San Daniele, IT 33038 |
| Product Code | KWS |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-11-13 |
| Decision Date | 2015-05-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08033390086516 | K143256 | 000 |
| 08033390086509 | K143256 | 000 |
| 08033390086493 | K143256 | 000 |
| 08033390086486 | K143256 | 000 |