510(k) K153317
K153317 is an FDA 510(k) premarket notification submitted by Orthocon, Inc. for the device "HEMASORBPLUS Resorbable Hemostatic Bone Putty". The FDA issued a decision of Substantially Equivalent on November 30, 2016. The device falls under product code MTJ (Wax, Bone), a Class U device. Orthocon, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 30, 2016
- Date Received
- November 18, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Wax, Bone
- Device Class
- Class U
- Regulation Number
- Review Panel
- OR
- Submission Type