The following data is part of a premarket notification filed by Exactech, Inc. with the FDA for Exactech Equinox Superior/posterior Augment Reverse Shoulder Glenoid Baseplate - Left & Right.
| Device ID | K131575 |
| 510k Number | K131575 |
| Device Name: | EXACTECH EQUINOX SUPERIOR/POSTERIOR AUGMENT REVERSE SHOULDER GLENOID BASEPLATE - LEFT & RIGHT |
| Classification | Shoulder Prosthesis, Reverse Configuration |
| Applicant | EXACTECH, INC. 2320 N.W. 66TH CT. Gainesville, FL 32653 |
| Contact | Patrick Hughes |
| Correspondent | Patrick Hughes EXACTECH, INC. 2320 N.W. 66TH CT. Gainesville, FL 32653 |
| Product Code | PHX |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-31 |
| Decision Date | 2013-07-03 |
| Summary: | summary |