Clearance Summary
29-200 TO 29-230 VARIOUS BONE MALLETS(WIHIGER, DOY received FDA 510(k) clearance under submission number K851789, sponsored by Artiberia. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 1985-06-20.
- Submission: K851789
- Applicant / Sponsor: Artiberia
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4800
- Decision date: 1985-06-20
Classification & Regulation
This clearance is catalogued under FDA product code GFJ and 21 CFR 878.4800, within the General, Plastic Surgery review panel as a Class I device.