The following data is part of a premarket notification filed by Exactech, Inc. with the FDA for Exactech Equinoxe Proximal Humerus Fracture Plate System.
| Device ID | K093978 |
| 510k Number | K093978 |
| Device Name: | EXACTECH EQUINOXE PROXIMAL HUMERUS FRACTURE PLATE SYSTEM |
| Classification | Plate, Fixation, Bone |
| Applicant | EXACTECH, INC. 2320 N.W. 66TH CT. Gainesville, FL 32653 |
| Contact | Shing Jen Tai |
| Correspondent | Shing Jen Tai EXACTECH, INC. 2320 N.W. 66TH CT. Gainesville, FL 32653 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-24 |
| Decision Date | 2010-05-11 |
| Summary: | summary |