Clearance Summary
MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty received FDA 510(k) clearance under submission number K220315, sponsored by Orthocon, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Unknown review panel. The statutory decision date of record is 2022-03-11.
- Submission: K220315
- Applicant / Sponsor: Orthocon, Inc.
- Clearance pathway: Traditional
- Review panel: Unknown
- Device class:
- Decision date: 2022-03-11
Classification & Regulation
This clearance is catalogued under FDA product code MTJ , within the Unknown review panel as a device.