510(k) K060794
K060794 is an FDA 510(k) premarket notification submitted by Medtronic Sofamor Danek for the device "PROGENIX DBM PUTTY AND PASTE". The FDA issued a decision of Substantially Equivalent on December 18, 2006. The device falls under product code MBP (Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)), a Class II device regulated under 21 CFR 888.3045. Medtronic Sofamor Danek has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 18, 2006
- Date Received
- March 23, 2006
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)
- Device Class
- Class II
- Regulation Number
- 888.3045
- Review Panel
- OR
- Submission Type