Clearance Summary
Osteo3 ZP Putty received FDA 510(k) clearance under submission number K193075, sponsored by Sirakoss , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2020-06-09.
- Submission: K193075
- Applicant / Sponsor: Sirakoss , Ltd.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3045
- Decision date: 2020-06-09
Classification & Regulation
This clearance is catalogued under FDA product code MQV and 21 CFR 888.3045, within the Orthopedic review panel as a Class II device.