The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Infinity (tm) Total Ankle System; Inbone Total Ankle System.
| Device ID | K141740 |
| 510k Number | K141740 |
| Device Name: | INFINITY (TM) TOTAL ANKLE SYSTEM; INBONE TOTAL ANKLE SYSTEM |
| Classification | Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer |
| Applicant | WRIGHT MEDICAL TECHNOLOGY, INC. 1023 CHERRY ROAD Memphis, TN 38117 |
| Contact | Jeanine Redden |
| Correspondent | Jeanine Redden 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 | 2014-06-27 |
| Decision Date | 2015-03-05 |
| Summary: | summary |