510(k) K172688
K172688 is an FDA 510(k) premarket notification submitted by Skeletal Dynamics, LLC for the device "Align Radial Head System". The FDA issued a decision of Substantially Equivalent on December 22, 2017. The device falls under product code KWI (Prosthesis, Elbow, Hemi-, Radial, Polymer), a Class II device regulated under 21 CFR 888.3170. Skeletal Dynamics, LLC has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 22, 2017
- Date Received
- September 6, 2017
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Elbow, Hemi-, Radial, Polymer
- Device Class
- Class II
- Regulation Number
- 888.3170
- Review Panel
- OR
- Submission Type