The following data is part of a premarket notification filed by Exactech, Inc. with the FDA for Equinoxe Uhmwpe 12* Posterior Augment Pegged Glenoid, Small / Medium / Large / Extra-large, Left / Right.
| Device ID | K111379 |
| 510k Number | K111379 |
| Device Name: | EQUINOXE UHMWPE 12* POSTERIOR AUGMENT PEGGED GLENOID, SMALL / MEDIUM / LARGE / EXTRA-LARGE, LEFT / RIGHT |
| Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented |
| Applicant | EXACTECH, INC. 2320 N.W. 66TH CT. Gainesville, FL 32653 |
| Contact | Graham L Cuthbert |
| Correspondent | Graham L Cuthbert 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 | 2011-05-17 |
| Decision Date | 2011-06-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10885862199584 | K111379 | 000 |
| 10885862199577 | K111379 | 000 |
| 10885862199560 | K111379 | 000 |
| 10885862199553 | K111379 | 000 |
| 10885862198525 | K111379 | 000 |
| 10885862198518 | K111379 | 000 |
| 10885862198501 | K111379 | 000 |
| 10885862198495 | K111379 | 000 |