510(k) K193067
K193067 is an FDA 510(k) premarket notification submitted by Wrightmedicaltechnologyinc for the device "The INBONE Total Ankle System, the INFINITY Total Ankle System and the INVISION Total Ankle Revision System". The FDA issued a decision of Substantially Equivalent on June 8, 2020. The device falls under product code HSN (Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer), a Class II device regulated under 21 CFR 888.3110. Wrightmedicaltechnologyinc has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 8, 2020
- Date Received
- November 4, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
- Device Class
- Class II
- Regulation Number
- 888.3110
- Review Panel
- OR
- Submission Type