The following data is part of a premarket notification filed by Limacorporate S.p.a. with the FDA for Smr Reverse Liner.
| Device ID | K220792 |
| 510k Number | K220792 |
| Device Name: | SMR Reverse Liner |
| 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 | Michela Zanotto |
| Correspondent | Lacey Harbour Lima USA Inc. 2001 NE Green Oaks Blvd. Ste.100 Arlington, TX 76006 |
| Product Code | MBF |
| Subsequent Product Code | KWS |
| Subsequent Product Code | KWT |
| Subsequent Product Code | PAO |
| Subsequent Product Code | PHX |
| CFR Regulation Number | 888.3670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-03-18 |
| Decision Date | 2022-05-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08033390204576 | K220792 | 000 |
| 08033390173957 | K220792 | 000 |
| 08033390196185 | K220792 | 000 |
| 08033390196208 | K220792 | 000 |
| 08033390196215 | K220792 | 000 |
| 08033390196222 | K220792 | 000 |
| 08033390196239 | K220792 | 000 |
| 08033390199063 | K220792 | 000 |
| 08033390204545 | K220792 | 000 |
| 08033390204552 | K220792 | 000 |
| 08033390204569 | K220792 | 000 |
| 08033390173940 | K220792 | 000 |