The following data is part of a premarket notification filed by Limacorporate with the FDA for Smr Tt Hybrid Glenoid, Smr 3-pegs Cemented Glenoid.
| Device ID | K213785 |
| 510k Number | K213785 |
| Device Name: | SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented Glenoid |
| Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented |
| Applicant | LimaCorporate Via Nazionale, 52 Villanova Di San Daniele Del Friuli, IT 33038 |
| Contact | Roberto Gabetta |
| Correspondent | Lacey Harbour Lima USA Inc. 2001 NE Green Oaks Blvd. Ste. 100 Arlington, TX 76006 |
| Product Code | KWS |
| Subsequent Product Code | KWT |
| Subsequent Product Code | MBF |
| Subsequent Product Code | PHF |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-06 |
| Decision Date | 2022-05-13 |