Clearance Summary
H-H HUNTER ACTIVE TENDON IMPLANT PC received FDA 510(k) clearance under submission number K872284, sponsored by Holter-Hausner Intl.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 1987-09-28.
- Submission: K872284
- Applicant / Sponsor: Holter-Hausner Intl.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3025
- Decision date: 1987-09-28
Classification & Regulation
This clearance is catalogued under FDA product code HXA and 21 CFR 888.3025, within the Orthopedic review panel as a Class II device.