Clearance Summary
NEWFIX EXTERNAL FIXATION SYSTEM received FDA 510(k) clearance under submission number K101338, sponsored by Technologia Y Diseno Industrial, S.A DE C.V. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2011-03-14.
- Submission: K101338
- Applicant / Sponsor: Technologia Y Diseno Industrial, S.A DE C.V
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3030
- Decision date: 2011-03-14
Classification & Regulation
This clearance is catalogued under FDA product code KTT and 21 CFR 888.3030, within the Orthopedic review panel as a Class II device.