The following data is part of a premarket notification filed by Limacorporate S.p.a. with the FDA for Smr 3-pegs Glenoids.
| Device ID | K153722 |
| 510k Number | K153722 |
| Device Name: | SMR 3-Pegs Glenoids |
| Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented |
| Applicant | Limacorporate S.p.A. via Nazionale, 52 Villanova Di San Daniele, IT 33038 |
| Contact | Emmanuele Buttazzoni |
| Correspondent | Stephen Peoples Peoples & Associates Consulting, LLC 5010 Lodge Pole Lane Fort Wayne, IN 46814 |
| Product Code | KWS |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-28 |
| Decision Date | 2016-04-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08033390114349 | K153722 | 000 |
| 08033390114295 | K153722 | 000 |
| 08033390114004 | K153722 | 000 |
| 08033390113991 | K153722 | 000 |
| 08033390119399 | K153722 | 000 |
| 08033390114325 | K153722 | 000 |
| 08033390113878 | K153722 | 000 |