The following data is part of a premarket notification filed by Limacorporate S.p.a. with the FDA for Smr 3-pegs Glenoids.
| Device ID | K130642 |
| 510k Number | K130642 |
| Device Name: | SMR 3-PEGS GLENOIDS |
| Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented |
| Applicant | LIMACORPORATE S.P.A. P.O. BOX 696 Winona Lake, IN 46590 -696 |
| Contact | Cheryl Hastings |
| Correspondent | Cheryl Hastings LIMACORPORATE S.P.A. P.O. BOX 696 Winona Lake, IN 46590 -696 |
| Product Code | KWS |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-11 |
| Decision Date | 2013-06-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08033390095402 | K130642 | 000 |
| 08033390023597 | K130642 | 000 |
| 08033390122375 | K130642 | 000 |
| 08033390122368 | K130642 | 000 |
| 08033390122351 | K130642 | 000 |
| 08033390095396 | K130642 | 000 |
| 08033390095389 | K130642 | 000 |
| 08033390095341 | K130642 | 000 |
| 08033390095334 | K130642 | 000 |
| 08033390060998 | K130642 | 000 |
| 08033390095419 | K130642 | 000 |
| 08033390095365 | K130642 | 000 |
| 08033390023603 | K130642 | 000 |
| 08033390105958 | K130642 | 000 |
| 08033390095372 | K130642 | 000 |
| 08033390095358 | K130642 | 000 |
| 08033390095327 | K130642 | 000 |
| 08033390023580 | K130642 | 000 |
| 08033390096362 | K130642 | 000 |
| 08033390096355 | K130642 | 000 |
| 08033390119382 | K130642 | 000 |
| 08033390119375 | K130642 | 000 |
| 08033390105989 | K130642 | 000 |
| 08033390105972 | K130642 | 000 |
| 08033390105965 | K130642 | 000 |
| 08033390060974 | K130642 | 000 |