Clearance Summary
Signature ONE System received FDA 510(k) clearance under submission number K212560, sponsored by Orthosoft Inc (D/B/A Zimmer Cas). The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2021-10-12.
- Submission: K212560
- Applicant / Sponsor: Orthosoft Inc (D/B/A Zimmer Cas)
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3660
- Decision date: 2021-10-12
Classification & Regulation
This clearance is catalogued under FDA product code QHE and 21 CFR 888.3660, within the Orthopedic review panel as a Class II device.