The following data is part of a premarket notification filed by Limacorporate S.p.a. with the FDA for Tema Elbow System - Line Extension.
| Device ID | K222807 |
| 510k Number | K222807 |
| Device Name: | TEMA Elbow System - Line Extension |
| Classification | Prosthesis, Elbow, Semi-constrained, Cemented |
| Applicant | LimaCorporate S.p.A. Via Nazionale 52 Villanova Di San Daniele Del Friuli, IT 33038 |
| Contact | Marco Tallerico |
| Correspondent | Kenneth Newman Lima USA Inc. 2001 NE Green Oaks Blvd. Ste. 100 Arlington, TX 76006 |
| Product Code | JDB |
| CFR Regulation Number | 888.3160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-09-16 |
| Decision Date | 2022-10-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08033390231459 | K222807 | 000 |
| 08033390150941 | K222807 | 000 |
| 08033390173186 | K222807 | 000 |
| 08033390173230 | K222807 | 000 |
| 08033390175449 | K222807 | 000 |
| 08033390175456 | K222807 | 000 |
| 08033390196802 | K222807 | 000 |
| 08033390196819 | K222807 | 000 |
| 08033390196826 | K222807 | 000 |
| 08033390196833 | K222807 | 000 |
| 08033390231435 | K222807 | 000 |
| 08033390231442 | K222807 | 000 |
| 08033390150934 | K222807 | 000 |