510(k) K102180
K102180 is an FDA 510(k) premarket notification submitted by Small Bone Innovations, Inc. for the device "RHEAD RADIAL HEAD EXTENDED STEMS". The FDA issued a decision of Substantially Equivalent on December 20, 2010. 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
- December 20, 2010
- Date Received
- August 2, 2010
- 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