The following data is part of a premarket notification filed by Integra Lifesciences Corporation with the FDA for Cadence Total Ankle System.
| Device ID | K201507 |
| 510k Number | K201507 |
| Device Name: | Cadence Total Ankle System |
| Classification | Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer |
| Applicant | Integra Lifesciences Corporation 11101 Metric Blvd Austin, TX 78758 |
| Contact | Cassidy Lemkau |
| Correspondent | Cassidy Lemkau Integra Lifesciences Corporation 11101 Metric Blvd Austin, TX 78758 |
| Product Code | HSN |
| CFR Regulation Number | 888.3110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-05 |
| Decision Date | 2020-06-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10381780527206 | K201507 | 000 |
| 00885556852521 | K201507 | 000 |
| 00885556852538 | K201507 | 000 |
| 00885556852545 | K201507 | 000 |
| 00885556852606 | K201507 | 000 |
| 00885556852613 | K201507 | 000 |
| 00885556852620 | K201507 | 000 |
| 00885556852637 | K201507 | 000 |
| 10381780527107 | K201507 | 000 |
| 10381780527114 | K201507 | 000 |
| 10381780527121 | K201507 | 000 |
| 10381780527138 | K201507 | 000 |
| 10381780527145 | K201507 | 000 |
| 10381780527169 | K201507 | 000 |
| 10381780527176 | K201507 | 000 |
| 10381780527183 | K201507 | 000 |
| 10381780527190 | K201507 | 000 |
| 00885556852514 | K201507 | 000 |