The following data is part of a premarket notification filed by Exactech, Inc. with the FDA for Equinoxe Reverse Shoulder Compression Screw / 38mm And 42mm Glenosphere / Superior Augment Glenoid Plate, 10 Degrees....
| Device ID | K110708 |
| 510k Number | K110708 |
| Device Name: | EQUINOXE REVERSE SHOULDER COMPRESSION SCREW / 38MM AND 42MM GLENOSPHERE / SUPERIOR AUGMENT GLENOID PLATE, 10 DEGREES... |
| 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 | 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 | 2011-03-14 |
| Decision Date | 2011-04-01 |
| Summary: | summary |