Clearance Summary
MARNE M.T.P.J. ORTHOPEDIC IMPLANT received FDA 510(k) clearance under submission number K781380, sponsored by Farah , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 1979-02-21.
- Submission: K781380
- Applicant / Sponsor: Farah , Ltd.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3230
- Decision date: 1979-02-21
Classification & Regulation
This clearance is catalogued under FDA product code KYJ and 21 CFR 888.3230, within the Orthopedic review panel as a Class II device.