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 |