Clearance Summary
OptiFix AT Absorbable Fixation System with Articulating Technology 30 Fasteners, OptiFix AT Absorbable Fixation System with Articulating Technology 15 Fasteners received FDA 510(k) clearance under submission number K191287, sponsored by Davol Inc., Subsidiary of C.R. Bard. The device was reviewed via the Special premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2019-07-16.
- Submission: K191287
- Applicant / Sponsor: Davol Inc., Subsidiary of C.R. Bard
- Clearance pathway: Special
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4750
- Decision date: 2019-07-16
Classification & Regulation
This clearance is catalogued under FDA product code GDW and 21 CFR 878.4750, within the General, Plastic Surgery review panel as a Class II device.