Clearance Summary
LACTOSORB POP RIVET received FDA 510(k) clearance under submission number K951658, 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 1995-07-25.
- Submission: K951658
- Applicant / Sponsor: Poly-Medics,Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3030
- Decision date: 1995-07-25
Classification & Regulation
This clearance is catalogued under FDA product code JDR and 21 CFR 888.3030, within the Orthopedic review panel as a Class II device.