Clearance Summary
BIOABSORBABLE BANKART TACK received FDA 510(k) clearance under submission number K973849, sponsored by Hogan & Hartson. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 1998-01-06.
- Submission: K973849
- Applicant / Sponsor: Hogan & Hartson
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3030
- Decision date: 1998-01-06
Classification & Regulation
This clearance is catalogued under FDA product code MAI and 21 CFR 888.3030, within the Orthopedic review panel as a Class II device.