The following data is part of a premarket notification filed by Limacorporate S.p.a. with the FDA for Smr Shoulder System - Cta Humeral Heads.
| Device ID | K110847 |
| 510k Number | K110847 |
| Device Name: | SMR SHOULDER SYSTEM - CTA HUMERAL HEADS |
| 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 | 2011-03-28 |
| Decision Date | 2011-07-15 |
| Summary: | summary |