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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08033390193078 | K201905 | 000 |
| 08033390193054 | K201905 | 000 |
| 08033390193023 | K201905 | 000 |
| 08033390193016 | K201905 | 000 |
| 08033390193009 | K201905 | 000 |
| 08033390191616 | K201905 | 000 |
| 08033390156974 | K201905 | 000 |
| 08033390156967 | K201905 | 000 |
| 08033390230599 | K201905 | 000 |