The following data is part of a premarket notification filed by Limacorporate S.p.a. with the FDA for Smr Resurfacing Shoulder System- Humeral Heads, Cta Humeral Heads.
| Device ID | K112900 |
| 510k Number | K112900 |
| Device Name: | SMR RESURFACING SHOULDER SYSTEM- HUMERAL HEADS, CTA HUMERAL HEADS |
| Classification | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented |
| 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 | HSD |
| CFR Regulation Number | 888.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-10-03 |
| Decision Date | 2012-06-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08033390111263 | K112900 | 000 |
| 08033390001281 | K112900 | 000 |
| 08033390022668 | K112900 | 000 |
| 08033390038621 | K112900 | 000 |
| 08033390038416 | K112900 | 000 |
| 08033390038423 | K112900 | 000 |
| 08033390104692 | K112900 | 000 |
| 08033390104708 | K112900 | 000 |
| 08033390104715 | K112900 | 000 |
| 08033390104722 | K112900 | 000 |
| 08033390111232 | K112900 | 000 |
| 08033390111249 | K112900 | 000 |
| 08033390111256 | K112900 | 000 |
| 08033390001274 | K112900 | 000 |