Clearance Summary
TENTATIVELY POLARUS EX ROD received FDA 510(k) clearance under submission number K952534, sponsored by Acu-Med, 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 1995-07-13.
- Submission: K952534
- Applicant / Sponsor: Acu-Med, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3020
- Decision date: 1995-07-13
Classification & Regulation
This clearance is catalogued under FDA product code HSB and 21 CFR 888.3020, within the Orthopedic review panel as a Class II device.