Clearance Summary
ORTHOFLEX ROD received FDA 510(k) clearance under submission number K102601, sponsored by Ortho-Pro, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2011-01-14.
- Submission: K102601
- Applicant / Sponsor: Ortho-Pro, LLC
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3720
- Decision date: 2011-01-14
Classification & Regulation
This clearance is catalogued under FDA product code KWH and 21 CFR 888.3720, within the Orthopedic review panel as a Class II device.