510(k) K153609
K153609 is an FDA 510(k) premarket notification submitted by In2bones USA, LLC for the device "RTS Flexible 1 MPJ Implant w/Grommets". The FDA issued a decision of Substantially Equivalent on September 8, 2016. The device falls under product code KWH (Prosthesis, Toe, Constrained, Polymer), a Class II device regulated under 21 CFR 888.3720. In2bones USA, LLC has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 8, 2016
- Date Received
- December 17, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Toe, Constrained, Polymer
- Device Class
- Class II
- Regulation Number
- 888.3720
- Review Panel
- OR
- Submission Type