510(k) K071121
K071121 is an FDA 510(k) premarket notification submitted by Biomatlante for the device "TRIBONE 80". The FDA issued a decision of Substantially Equivalent on Sep 11, 2007. The device falls under product code MQV (Filler, Bone Void, Calcium Compound), a Class II device regulated under 21 CFR 888.3045. Biomatlante has 7 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 11, 2007
- Date Received
- Apr 20, 2007
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Filler, Bone Void, Calcium Compound
- Device Class
- Class II
- Regulation Number
- 888.3045
- Review Panel
- OR
- Submission Type
- 510(k)