Clearance Summary
27-230 TO 27-234 VARIOUS CAST BREAKERS, WOLF received FDA 510(k) clearance under submission number K851786, sponsored by Artiberia. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 1985-07-09.
- Submission: K851786
- Applicant / Sponsor: Artiberia
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class I
- Regulation citation: 21 CFR 888.5980
- Decision date: 1985-07-09
Classification & Regulation
This clearance is catalogued under FDA product code LGG and 21 CFR 888.5980, within the Orthopedic review panel as a Class I device.