The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Inbone ( I And Ii) Total Ankle Systems.
| Device ID | K123059 |
| 510k Number | K123059 |
| Device Name: | INBONE ( I AND II) TOTAL ANKLE SYSTEMS |
| Classification | Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer |
| Applicant | WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
| Contact | Ryan Bormann |
| Correspondent | Ryan Bormann WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
| Product Code | HSN |
| CFR Regulation Number | 888.3110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-01 |
| Decision Date | 2013-03-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840420124876 | K123059 | 000 |
| 00840420124739 | K123059 | 000 |
| 00840420124746 | K123059 | 000 |
| 00840420124753 | K123059 | 000 |
| 00840420124760 | K123059 | 000 |
| 00840420124777 | K123059 | 000 |
| 00840420124784 | K123059 | 000 |
| 00840420124791 | K123059 | 000 |
| 00840420124807 | K123059 | 000 |
| 00840420124814 | K123059 | 000 |
| 00840420124821 | K123059 | 000 |
| 00840420124838 | K123059 | 000 |
| 00840420124845 | K123059 | 000 |
| 00840420124852 | K123059 | 000 |
| 00840420124869 | K123059 | 000 |
| 00840420124722 | K123059 | 000 |