The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Inbone Ii Total Ankle Replacement.
| Device ID | K100886 |
| 510k Number | K100886 |
| Device Name: | INBONE II TOTAL ANKLE REPLACEMENT |
| Classification | Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer |
| Applicant | WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
| Contact | Kelsey Lee |
| Correspondent | Kelsey Lee 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 | 2010-03-30 |
| Decision Date | 2010-08-26 |
| Summary: | summary |