The following data is part of a premarket notification filed by Limacorporate S.p.a with the FDA for Smr Tt Augmented Glenoid System.
| Device ID | K200171 |
| 510k Number | K200171 |
| Device Name: | SMR TT Augmented Glenoid System |
| Classification | Shoulder Prosthesis, Reverse Configuration |
| Applicant | LimaCorporate S.p.A Via Nazionale 52 Villanova Di San Daniele Del Friuli, IT 33038 |
| Contact | Michela Zanotto |
| Correspondent | Lacey Harbour Lima USA Inc. 2001 NE Green Arlington, TX 76006 |
| Product Code | PHX |
| Subsequent Product Code | KWS |
| Subsequent Product Code | KWT |
| Subsequent Product Code | MBF |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-01-23 |
| Decision Date | 2020-11-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08033390185110 | K200171 | 000 |
| 08033390106764 | K200171 | 000 |
| 08033390106771 | K200171 | 000 |
| 08033390106788 | K200171 | 000 |
| 08033390161503 | K200171 | 000 |
| 08033390170185 | K200171 | 000 |
| 08033390180047 | K200171 | 000 |
| 08033390180313 | K200171 | 000 |
| 08033390180320 | K200171 | 000 |
| 08033390180337 | K200171 | 000 |
| 08033390106757 | K200171 | 000 |