Clearance Summary
GSO BONE FIXATION FASTENERS received FDA 510(k) clearance under submission number K063589, sponsored by Gold Standard Orthopaedics, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2007-01-31.
- Submission: K063589
- Applicant / Sponsor: Gold Standard Orthopaedics, LLC
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3040
- Decision date: 2007-01-31
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.