Clearance Summary
FERROFIBRE STAINLESS STEEL SUTURES, MODEL 610 SERIES SIZES (USP) 5-0 TO #5 received FDA 510(k) clearance under submission number K081060, sponsored by Core Essence Orthopaedics, LLC. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2008-12-24.
- Submission: K081060
- Applicant / Sponsor: Core Essence Orthopaedics, LLC
- Clearance pathway: Abbreviated
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4495
- Decision date: 2008-12-24
Classification & Regulation
This clearance is catalogued under FDA product code GAQ and 21 CFR 878.4495, within the General, Plastic Surgery review panel as a Class II device.