The following data is part of a premarket notification filed by Exactech Inc with the FDA for Exactech Equinoxe Humeral Reconstruction Prosthesis Extra-small Proximal Bodies.
| Device ID | K162903 |
| 510k Number | K162903 |
| Device Name: | Exactech Equinoxe Humeral Reconstruction Prosthesis Extra-Small Proximal Bodies |
| Classification | Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented |
| Applicant | Exactech Inc 2320 NW 66th Court Gainesville, FL 32653 |
| Contact | Thomas Mcnamara |
| Correspondent | Thomas Mcnamara Exactech Inc 2320 NW 66th Court Gainesville, FL 32653 |
| Product Code | KWT |
| Subsequent Product Code | HSD |
| Subsequent Product Code | KWS |
| Subsequent Product Code | PHX |
| CFR Regulation Number | 888.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-10-17 |
| Decision Date | 2017-02-27 |
| Summary: | summary |