Clearance Summary
OPTEFORM, OSTEOFIL, RTI ALLOGRAFT PASTE IC, RTI ALLOGRAFT STRIP IC received FDA 510(k) clearance under submission number K043421, sponsored by Regeneration Technologies, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2005-02-16.
- Submission: K043421
- Applicant / Sponsor: Regeneration Technologies, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3045
- Decision date: 2005-02-16
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.