Clearance Summary
KOMET MEDICAL KIRSCHNER WIRES, STEINMANN PINS AND GUIDE PINS AND SCREWS received FDA 510(k) clearance under submission number K131264, sponsored by Gebr. Brasseler GmbH & Co. KG. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2013-07-26.
- Submission: K131264
- Applicant / Sponsor: Gebr. Brasseler GmbH & Co. KG
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3040
- Decision date: 2013-07-26
Classification & Regulation
This clearance is catalogued under FDA product code HWC and 21 CFR 888.3040, within the Orthopedic review panel as a Class II device.