Clearance Summary
NORMED ANKLE FIX SYSTEM 4.0 AND NORMED ANKLE FIX PLUS SYSTEM 4.0 received FDA 510(k) clearance under submission number K123347, sponsored by Normed Medizin-Technik GmbH. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2013-08-02.
- Submission: K123347
- Applicant / Sponsor: Normed Medizin-Technik GmbH
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3030
- Decision date: 2013-08-02
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.