Clearance Summary
PASSIVE TENDON IMPLANT received FDA 510(k) clearance under submission number K780320, 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 1978-03-17.
- Submission: K780320
- Applicant / Sponsor: Holter-Hausner Intl.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3025
- Decision date: 1978-03-17
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.