The following data is part of a premarket notification filed by Exactech, Inc. with the FDA for Exactech Equinoxe Cage Glenoids.
| Device ID | K113309 |
| 510k Number | K113309 |
| Device Name: | EXACTECH EQUINOXE CAGE GLENOIDS |
| Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented |
| Applicant | EXACTECH, INC. 2320 NW 66TH COURT Gainesville, FL 32605 |
| Contact | Patrick Hughes |
| Correspondent | Patrick Hughes EXACTECH, INC. 2320 NW 66TH COURT Gainesville, FL 32605 |
| Product Code | KWS |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-08 |
| Decision Date | 2011-12-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10885862201034 | K113309 | 000 |
| 10885862085511 | K113309 | 000 |
| 10885862196347 | K113309 | 000 |
| 10885862172679 | K113309 | 000 |
| 10885862172686 | K113309 | 000 |
| 10885862172693 | K113309 | 000 |
| 10885862172709 | K113309 | 000 |
| 10885862172716 | K113309 | 000 |
| 10885862172723 | K113309 | 000 |
| 10885862196163 | K113309 | 000 |
| 10885862196170 | K113309 | 000 |
| 10885862200983 | K113309 | 000 |
| 10885862200990 | K113309 | 000 |
| 10885862201003 | K113309 | 000 |
| 10885862201010 | K113309 | 000 |
| 10885862201027 | K113309 | 000 |
| 10885862085504 | K113309 | 000 |