The following data is part of a premarket notification filed by Limacorporate S.p.a. with the FDA for Smr 140° Reverse Humeral Body.
Device ID | K201905 |
510k Number | K201905 |
Device Name: | SMR 140° Reverse Humeral Body |
Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer, Uncemented |
Applicant | LimaCorporate S.p.A. Via Nazionale 52 Villanova Di San Daniele Del Friuli, IT 33038 |
Contact | Giuseppe Valenti |
Correspondent | Lacey Harbour Lima USA Inc. 2001 NE Green Oaks Blvd. Ste. 100 Arlington, TX 76006 |
Product Code | MBF |
Subsequent Product Code | HSD |
Subsequent Product Code | KWS |
Subsequent Product Code | KWT |
Subsequent Product Code | PHX |
CFR Regulation Number | 888.3670 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-07-09 |
Decision Date | 2020-12-17 |