The following data is part of a premarket notification filed by Exactech, Inc. with the FDA for Exactech Equinoxe Shoulder System Torque Defining Screw And Short Replicator Plate.
| Device ID | K121067 |
| 510k Number | K121067 |
| Device Name: | EXACTECH EQUINOXE SHOULDER SYSTEM TORQUE DEFINING SCREW AND SHORT REPLICATOR PLATE |
| Classification | Shoulder Prosthesis, Reverse Configuration |
| Applicant | EXACTECH, INC. 2320 N.W. 66TH CT. Gainesville, FL 32653 |
| Contact | Lindy Knisely |
| Correspondent | Lindy Knisely EXACTECH, INC. 2320 N.W. 66TH CT. Gainesville, FL 32653 |
| Product Code | PHX |
| Subsequent Product Code | HSD |
| 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 | 2012-04-06 |
| Decision Date | 2012-12-06 |
| Summary: | summary |