510(k) K142828
K142828 is an FDA 510(k) premarket notification submitted by Biogennix for the device "osteoSPAN Morpheus". The FDA issued a decision of Substantially Equivalent on January 15, 2015. The device falls under product code MQV (Filler, Bone Void, Calcium Compound), a Class II device regulated under 21 CFR 888.3045. Biogennix has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 15, 2015
- Date Received
- September 30, 2014
- 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