Clearance Summary
02810-01/02810-02 ORTHORANGER II/02810-3 ROM 360 received FDA 510(k) clearance under submission number K913079, sponsored by Lucas Sensing 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 1991-09-25.
- Submission: K913079
- Applicant / Sponsor: Lucas Sensing Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class I
- Regulation citation: 21 CFR 888.1500
- Decision date: 1991-09-25
Classification & Regulation
This clearance is catalogued under FDA product code KQX and 21 CFR 888.1500, within the Orthopedic review panel as a Class I device.