The following data is part of a premarket notification filed by Exactech, Inc. with the FDA for Equinoxe Glenoid, Uhmwpe 16 Ps=osterior Augment Pegged, Small, Left/right.
| Device ID | K121220 |
| 510k Number | K121220 |
| Device Name: | EQUINOXE GLENOID, UHMWPE 16 PS=OSTERIOR AUGMENT PEGGED, SMALL, LEFT/RIGHT |
| Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented |
| 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 | KWS |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-23 |
| Decision Date | 2012-11-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10885862228376 | K121220 | 000 |
| 10885862228369 | K121220 | 000 |
| 10885862228352 | K121220 | 000 |
| 10885862228345 | K121220 | 000 |
| 10885862228338 | K121220 | 000 |
| 10885862228321 | K121220 | 000 |
| 10885862228314 | K121220 | 000 |
| 10885862228307 | K121220 | 000 |