The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Infinity Total Ankle System.
| Device ID | K172633 |
| 510k Number | K172633 |
| Device Name: | INFINITY Total Ankle System |
| Classification | Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer |
| Applicant | Wright Medical Technology, Inc. 1023 Cherry Road Memphis, TN 38117 |
| Contact | Tara Conrad |
| Correspondent | Tara Conrad Wright Medical Technology, Inc. 1023 Cherry Road Memphis, TN 38117 |
| Product Code | HSN |
| CFR Regulation Number | 888.3110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-01 |
| Decision Date | 2018-04-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889797101554 | K172633 | 000 |
| 00889797101547 | K172633 | 000 |
| 00889797101530 | K172633 | 000 |
| 00889797101523 | K172633 | 000 |
| 00889797101516 | K172633 | 000 |