Clearance Summary
BARNES FEMORAL LENGTHENING DEVICE received FDA 510(k) clearance under submission number K895243, sponsored by Piedmont Sports Medicine & Orthopaedic Clinic. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 1990-08-10.
- Submission: K895243
- Applicant / Sponsor: Piedmont Sports Medicine & Orthopaedic Clinic
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3030
- Decision date: 1990-08-10
Classification & Regulation
This clearance is catalogued under FDA product code HRS and 21 CFR 888.3030, within the Orthopedic review panel as a Class II device.