Clearance Summary
TENDON ROD MODEL OR41PO3-6 received FDA 510(k) clearance under submission number K781943, 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 1978-12-04.
- Submission: K781943
- Applicant / Sponsor: Holter-Hausner Intl.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3025
- Decision date: 1978-12-04
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.