The following data is part of a premarket notification filed by Exactech, Inc. with the FDA for Exactech Equinoxe Xl Keeled Glenoid, Pegged Glenoid, Exactech Equinoxe Cage, Glenoid Contd..
| Device ID | K093430 |
| 510k Number | K093430 |
| Device Name: | EXACTECH EQUINOXE XL KEELED GLENOID, PEGGED GLENOID, EXACTECH EQUINOXE CAGE, GLENOID CONTD. |
| Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented |
| Applicant | EXACTECH, INC. 2320 N.W. 66TH CT. Gainesville, FL 32653 |
| Contact | Graham Cuthbert |
| Correspondent | Graham Cuthbert EXACTECH, INC. 2320 N.W. 66TH CT. Gainesville, FL 32653 |
| Product Code | KWS |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-11-03 |
| Decision Date | 2010-09-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10885862084538 | K093430 | 000 |
| 10885862084460 | K093430 | 000 |