Clearance Summary
ORTHODOC PREOPERATIVE PLANNER MODEL 500 received FDA 510(k) clearance under submission number K960685, sponsored by Integrated Surgical Systems, 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 1997-01-17.
- Submission: K960685
- Applicant / Sponsor: Integrated Surgical Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class I
- Regulation citation: 21 CFR 888.4800
- Decision date: 1997-01-17
Classification & Regulation
This clearance is catalogued under FDA product code HWT and 21 CFR 888.4800, within the Orthopedic review panel as a Class I device.