Clearance Summary
LACTOSORB TRAUMA PLATING SYSTEM received FDA 510(k) clearance under submission number K955729, sponsored by Poly-Medics,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 1996-02-14.
- Submission: K955729
- Applicant / Sponsor: Poly-Medics,Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3030
- Decision date: 1996-02-14
Classification & Regulation
This clearance is catalogued under FDA product code HRS and 21 CFR 888.3030, within the Orthopedic review panel as a Class II device.