Signature ONE System— 510(k) K192074

Name: FDA 510(k) clearance K192074
Creator: U.S. Food and Drug Administration
Published: 2019-08-30

Substantially Equivalent

Orthosoft Inc (D/B/A Zimmer Cas)

FDA 510(k) clearance K192074 for Signature ONE System, Substantially Equivalent on 2019-08-30. Applicant: Orthosoft Inc (D/B/A Zimmer Cas). Device class: 2.

Clearance details

Applicant: Orthosoft Inc (D/B/A Zimmer Cas)
Product code: Code QHE
Device class: Class 2
Regulation: 21 CFR 888.3660
Advisory panel: Orthopedic
Date received: 2019-08-02
Decision date: 2019-08-30
Decision: Substantially Equivalent
Clearance type: Special
Location: Montreal, CA

Download summary PDF View on FDA.gov ↗

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K232425 — Signature ONE System2023-12-12

Data sourced from openFDA. This site is unofficial and independent of the FDA.