510(k) K061146
K061146 is an FDA 510(k) premarket notification submitted by Small Bone Innovations, Inc. for the device "SBI ULNAR HEAD IMPLANT". The FDA issued a decision of Substantially Equivalent on July 19, 2006. The device falls under product code KXE (Prosthesis, Wrist, Hemi-, Ulnar), a Class II device regulated under 21 CFR 888.3810. Small Bone Innovations, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 19, 2006
- Date Received
- April 25, 2006
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Wrist, Hemi-, Ulnar
- Device Class
- Class II
- Regulation Number
- 888.3810
- Review Panel
- OR
- Submission Type