The following data is part of a premarket notification filed by Limacorporate S.p.a. with the FDA for Smr Lateralized Connectors With Screws.
| Device ID | K183042 |
| 510k Number | K183042 |
| Device Name: | SMR Lateralized Connectors With Screws |
| Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented |
| Applicant | Limacorporate S.p.A. Via Nazionale 52 Villanova Di San Daniele, IT 33038 |
| Contact | Roberto Gabetta |
| Correspondent | Stephen Peoples Peoples & Associates Consulting LLC 5010 Lodge Pole Lane Fort Wayne, IN 46814 |
| Product Code | KWS |
| Subsequent Product Code | KWT |
| Subsequent Product Code | MBF |
| Subsequent Product Code | PHX |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-02 |
| Decision Date | 2019-01-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08033390152174 | K183042 | 000 |
| 08033390153119 | K183042 | 000 |