510(k) K152005
K152005 is an FDA 510(k) premarket notification submitted by Orthocon, Inc. for the device "MONTAGE Settable, Resorbable Hemostatic Bone Putty". The FDA issued a decision of Substantially Equivalent on October 15, 2015. 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
- October 15, 2015
- Date Received
- July 20, 2015
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Wax, Bone
- Device Class
- Class U
- Regulation Number
- Review Panel
- OR
- Submission Type