Signature ONE System— 510(k) K260104

Substantially Equivalent

Orthosoft Inc. (d/b/a) Zimmer CAS

FDA 510(k) clearance K260104 for Signature ONE System, Substantially Equivalent on 2026-02-04. Applicant: Orthosoft Inc. (d/b/a) Zimmer CAS.

Clearance details

Applicant: Orthosoft Inc. (d/b/a) Zimmer CAS
Product code: Code QHE
Advisory panel: Orthopedic
Date received: 2026-01-13
Decision date: 2026-02-04
Decision: Substantially Equivalent
Clearance type: Special
Location: Montreal, CA

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