The following data is part of a premarket notification filed by Exactech Inc with the FDA for Optetrak Advanced Patella.
| Device ID | K160484 |
| 510k Number | K160484 |
| Device Name: | Optetrak Advanced Patella |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | EXACTECH INC 2320 NW 66TH CT Gainesville, FL 32653 |
| Contact | Patrick Hughes |
| Correspondent | Patrick Hughes EXACTECH INC 2320 NW 66TH CT Gainesville, FL 32653 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-22 |
| Decision Date | 2016-03-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10885862314307 | K160484 | 000 |
| 10885862313843 | K160484 | 000 |
| 10885862059598 | K160484 | 000 |
| 10885862059581 | K160484 | 000 |
| 10885862525185 | K160484 | 000 |
| 10885862059666 | K160484 | 000 |
| 10885862561732 | K160484 | 000 |
| 10885862561725 | K160484 | 000 |
| 10885862561718 | K160484 | 000 |
| 10885862531261 | K160484 | 000 |
| 10885862546500 | K160484 | 000 |
| 10885862314291 | K160484 | 000 |
| 10885862314284 | K160484 | 000 |
| 10885862314277 | K160484 | 000 |
| 10885862314260 | K160484 | 000 |
| 10885862617972 | K160484 | 000 |
| 10885862617965 | K160484 | 000 |
| 10885862606884 | K160484 | 000 |
| 10885862561756 | K160484 | 000 |
| 10885862561701 | K160484 | 000 |