The following data is part of a premarket notification filed by Exactech, Inc. with the FDA for Equinoxe Extra Short Humeral Head.
| Device ID | K140063 |
| 510k Number | K140063 |
| Device Name: | EQUINOXE EXTRA SHORT HUMERAL HEAD |
| Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented |
| 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 | KWS |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-01-10 |
| Decision Date | 2014-02-11 |
| Summary: | summary |