The following data is part of a premarket notification filed by Limacorporate S.p.a with the FDA for Smr Finned Short Stems.
| Device ID | K191963 |
| 510k Number | K191963 |
| Device Name: | SMR Finned Short Stems |
| 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 | Stephen Peoples Peoples & Associates Consulting LLC 5010 Lodge Pole Lane Fort Wayne, IN 46814 |
| 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 | 2019-07-23 |
| Decision Date | 2019-10-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08033390155557 | K191963 | 000 |
| 08033390155281 | K191963 | 000 |
| 08033390155304 | K191963 | 000 |
| 08033390155328 | K191963 | 000 |
| 08033390155359 | K191963 | 000 |
| 08033390155380 | K191963 | 000 |
| 08033390155403 | K191963 | 000 |
| 08033390155427 | K191963 | 000 |
| 08033390155441 | K191963 | 000 |
| 08033390155465 | K191963 | 000 |
| 08033390155489 | K191963 | 000 |
| 08033390155502 | K191963 | 000 |
| 08033390155526 | K191963 | 000 |
| 08033390172455 | K191963 | 000 |