Clearance Summary
SD TRANS-OSSEOUS FASTENER MODELS TOB 6 BOLT 32/50, TOB 6 BOLT 50/80, TOB 6 BOLT 80/140, TOB 6 WASHER MODELS 12MM 16MM 1M received FDA 510(k) clearance under submission number K982354, sponsored by Special Devices, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 1998-11-23.
- Submission: K982354
- Applicant / Sponsor: Special Devices, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3030
- Decision date: 1998-11-23
Classification & Regulation
This clearance is catalogued under FDA product code HTN and 21 CFR 888.3030, within the Orthopedic review panel as a Class II device.