The following data is part of a premarket notification filed by Exactech, Inc. with the FDA for Exactech Equinoxe, Platform Fracture Stem.
| Device ID | K101909 |
| 510k Number | K101909 |
| Device Name: | EXACTECH EQUINOXE, PLATFORM FRACTURE STEM |
| Classification | Shoulder Prosthesis, Reverse Configuration |
| Applicant | EXACTECH, INC. 2320 N.W. 66TH CT. Gainesville, FL 32653 |
| Contact | Graham L Cuthbert |
| Correspondent | Graham L Cuthbert EXACTECH, INC. 2320 N.W. 66TH CT. Gainesville, FL 32653 |
| Product Code | PHX |
| Subsequent Product Code | KWS |
| Subsequent Product Code | KWT |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-07-08 |
| Decision Date | 2010-08-02 |
| Summary: | summary |