The following data is part of a premarket notification filed by Limacorporate S.p.a. with the FDA for Smr Tt Metal Back Glenoid, Bone Graft Instruments.
| Device ID | K161120 |
| 510k Number | K161120 |
| Device Name: | SMR TT Metal Back Glenoid, Bone Graft Instruments |
| Classification | Shoulder Prosthesis, Reverse Configuration |
| Applicant | LIMACORPORATE S.P.A. VIA NAZIONALE 52 Villanova Di San Daniele, IT 33038 |
| Contact | Emanuele Buttazzoni |
| Correspondent | Stephen Peoples PEOPLES & ASSOCIATES CONSULTING LLC 5010 LODGE POLE LANE Fort Wayne, IN 46814 |
| Product Code | PHX |
| Subsequent Product Code | KWS |
| Subsequent Product Code | KWT |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-21 |
| Decision Date | 2017-02-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08033390118194 | K161120 | 000 |
| 08033390109543 | K161120 | 000 |
| 08033390105842 | K161120 | 000 |
| 08033390105859 | K161120 | 000 |
| 08033390105873 | K161120 | 000 |
| 08033390105880 | K161120 | 000 |
| 08033390105897 | K161120 | 000 |
| 08033390118255 | K161120 | 000 |
| 08033390118262 | K161120 | 000 |
| 08033390118279 | K161120 | 000 |
| 08033390118286 | K161120 | 000 |
| 08033390118293 | K161120 | 000 |
| 08033390118309 | K161120 | 000 |
| 08033390118316 | K161120 | 000 |
| 08033390108782 | K161120 | 000 |
| 08033390118187 | K161120 | 000 |
| 08033390109536 | K161120 | 000 |