Clearance Summary
PULLUP® Adjustable Juxtacortical Fixation Device received FDA 510(k) clearance under submission number K151004, sponsored by Sbm Sciences For Bio Materials. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2015-11-17.
- Submission: K151004
- Applicant / Sponsor: Sbm Sciences For Bio Materials
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3040
- Decision date: 2015-11-17
Classification & Regulation
This clearance is catalogued under FDA product code MBI and 21 CFR 888.3040, within the Orthopedic review panel as a Class II device.