Clearance Summary
Spider Frame External Fixation System received FDA 510(k) clearance under submission number K170482, sponsored by Tasarimmed Tibbi Mamuller Sanayi VE Ticaret A.S. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2017-09-27.
- Submission: K170482
- Applicant / Sponsor: Tasarimmed Tibbi Mamuller Sanayi VE Ticaret A.S
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3030
- Decision date: 2017-09-27
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.