510(k) K060038
K060038 is an FDA 510(k) premarket notification submitted by Small Bone Innovations, Inc. for the device "SBI RADIO-CAPITELLAR IMPLANT". The FDA issued a decision of Substantially Equivalent on March 30, 2006. The device falls under product code JDB (Prosthesis, Elbow, Semi-Constrained, Cemented), a Class II device regulated under 21 CFR 888.3160. Small Bone Innovations, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 30, 2006
- Date Received
- January 6, 2006
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Elbow, Semi-Constrained, Cemented
- Device Class
- Class II
- Regulation Number
- 888.3160
- Review Panel
- OR
- Submission Type