Clearance Summary
INNOVASIVE 2.8MM AND 3.5MM ROC EZ SUTURE BONE FASTENER received FDA 510(k) clearance under submission number K971922, sponsored by Innovasive Devices, 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 1997-08-07.
- Submission: K971922
- Applicant / Sponsor: Innovasive Devices, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3040
- Decision date: 1997-08-07
Classification & Regulation
This clearance is catalogued under FDA product code MBI and 21 CFR 888.3040, within the Orthopedic review panel as a Class II device.