The following data is part of a premarket notification filed by Turnkey Intergration Usa, Inc. with the FDA for May Humerus Plates.
| Device ID | K912936 |
| 510k Number | K912936 |
| Device Name: | MAY HUMERUS PLATES |
| Classification | Plate, Fixation, Bone |
| Applicant | TURNKEY INTERGRATION USA, INC. 8021 KNUE RD. SUITE 121 Indianapolis, IN 46250 |
| Contact | Stuart |
| Correspondent | Stuart TURNKEY INTERGRATION USA, INC. 8021 KNUE RD. SUITE 121 Indianapolis, IN 46250 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-05 |
| Decision Date | 1991-09-06 |