The following data is part of a premarket notification filed by Shoulder Options, Inc. with the FDA for Aft Proximal Humerus Fracture Plate.
| Device ID | K121672 |
| 510k Number | K121672 |
| Device Name: | AFT PROXIMAL HUMERUS FRACTURE PLATE |
| Classification | Plate, Fixation, Bone |
| Applicant | SHOULDER OPTIONS, INC. 100 E. SOUTH MAIN ST. P.O. BOX 1458 Waxhaw, NC 28173 |
| Contact | John Kapitan |
| Correspondent | John Kapitan SHOULDER OPTIONS, INC. 100 E. SOUTH MAIN ST. P.O. BOX 1458 Waxhaw, NC 28173 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-06-06 |
| Decision Date | 2012-10-01 |
| Summary: | summary |