The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Infinity Total Ankle System, Inbone Total Ankle System.
| Device ID | K191393 |
| 510k Number | K191393 |
| Device Name: | INFINITY 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 | Rachel Roberts |
| Correspondent | Rachel Roberts 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 | 2019-05-24 |
| Decision Date | 2019-08-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889797073097 | K191393 | 000 |
| 00889797072960 | K191393 | 000 |
| 00889797072977 | K191393 | 000 |
| 00889797072984 | K191393 | 000 |
| 00889797072991 | K191393 | 000 |
| 00889797073004 | K191393 | 000 |
| 00889797073011 | K191393 | 000 |
| 00889797073028 | K191393 | 000 |
| 00889797073035 | K191393 | 000 |
| 00889797073042 | K191393 | 000 |
| 00889797073059 | K191393 | 000 |
| 00889797073066 | K191393 | 000 |
| 00889797073073 | K191393 | 000 |
| 00889797073080 | K191393 | 000 |
| 00889797072953 | K191393 | 000 |