510(k) K231386
K231386 is an FDA 510(k) premarket notification submitted by Orthocon, Inc. for the device "Montage Flowable XRO Settable, Resorbable Hemostatic Bone Paste". The FDA issued a decision of Substantially Equivalent on July 11, 2023. 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
- July 11, 2023
- Date Received
- May 12, 2023
- 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