The following data is part of a premarket notification filed by Exactech Inc with the FDA for Vantage Total Ankle Flat Cut Talar Components.
| Device ID | K183343 |
| 510k Number | K183343 |
| Device Name: | Vantage Total Ankle Flat Cut Talar Components |
| Classification | Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer |
| Applicant | Exactech Inc 2320 NW 66th Court Gainesville, FL 32653 |
| Contact | Shing Jen Tai |
| Correspondent | Shing Jen Tai Exactech Inc 2320 NW 66th Court Gainesville, FL 32653 |
| Product Code | HSN |
| CFR Regulation Number | 888.3110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-03 |
| Decision Date | 2019-04-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10885862546326 | K183343 | 000 |
| 10885862546098 | K183343 | 000 |
| 10885862546081 | K183343 | 000 |
| 10885862546074 | K183343 | 000 |
| 10885862546067 | K183343 | 000 |
| 10885862546050 | K183343 | 000 |
| 10885862546043 | K183343 | 000 |
| 10885862546036 | K183343 | 000 |
| 10885862546029 | K183343 | 000 |
| 10885862546104 | K183343 | 000 |
| 10885862559050 | K183343 | 000 |
| 10885862546234 | K183343 | 000 |
| 10885862546319 | K183343 | 000 |
| 10885862546302 | K183343 | 000 |
| 10885862546296 | K183343 | 000 |
| 10885862546289 | K183343 | 000 |
| 10885862546272 | K183343 | 000 |
| 10885862546265 | K183343 | 000 |
| 10885862546258 | K183343 | 000 |
| 10885862546241 | K183343 | 000 |
| 10885862546012 | K183343 | 000 |