The following data is part of a premarket notification filed by Limacorporate S.p.a. with the FDA for Smr Shoulder System- Revision Stems.
| Device ID | K111212 |
| 510k Number | K111212 |
| Device Name: | SMR SHOULDER SYSTEM- REVISION STEMS |
| 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 | 2011-04-29 |
| Decision Date | 2011-07-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08033390001113 | K111212 | 000 |
| 08033390101950 | K111212 | 000 |
| 08033390101943 | K111212 | 000 |
| 08033390101936 | K111212 | 000 |
| 08033390068710 | K111212 | 000 |
| 08033390068703 | K111212 | 000 |
| 08033390038348 | K111212 | 000 |
| 08033390038331 | K111212 | 000 |
| 08033390023139 | K111212 | 000 |
| 08033390023122 | K111212 | 000 |
| 08033390023115 | K111212 | 000 |
| 08033390023108 | K111212 | 000 |
| 08033390023078 | K111212 | 000 |
| 08033390023061 | K111212 | 000 |
| 08033390023054 | K111212 | 000 |
| 08033390023047 | K111212 | 000 |
| 08033390023030 | K111212 | 000 |
| 08033390101967 | K111212 | 000 |
| 08033390101974 | K111212 | 000 |
| 08033390001106 | K111212 | 000 |
| 08033390001090 | K111212 | 000 |
| 08033390001083 | K111212 | 000 |
| 08033390001076 | K111212 | 000 |
| 08033390001069 | K111212 | 000 |
| 08033390001052 | K111212 | 000 |
| 08033390001045 | K111212 | 000 |
| 08033390102063 | K111212 | 000 |
| 08033390102056 | K111212 | 000 |
| 08033390102049 | K111212 | 000 |
| 08033390102032 | K111212 | 000 |
| 08033390102025 | K111212 | 000 |
| 08033390102018 | K111212 | 000 |
| 08033390102001 | K111212 | 000 |
| 08033390101998 | K111212 | 000 |
| 08033390101981 | K111212 | 000 |
| 08033390023023 | K111212 | 000 |