Signature ONE System
K-Number: K192074 · 2019-08-30
ApplicantOrthosoft Inc (D/B/A Zimmer Cas)
Decision Date2019-08-30
Product CodeQHE
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Signature ONE System is a medical device manufactured by Orthosoft Inc (D/B/A Zimmer Cas). It received FDA 510(k) clearance on 2019-08-30 under approval number K192074. The device is classified under product code QHE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Signature ONE System?
Signature ONE System is a medical device that received FDA 510(k) clearance on 2019-08-30. It is manufactured by Orthosoft Inc (D/B/A Zimmer Cas). The 510(k) number is K192074.
When was Signature ONE System approved by the FDA?
Signature ONE System received FDA 510(k) clearance on 2019-08-30, under approval number K192074.
What company makes Signature ONE System?
Signature ONE System is manufactured by Orthosoft Inc (D/B/A Zimmer Cas).
What is the FDA product code for Signature ONE System?
The FDA product code for Signature ONE System is QHE.
Other Devices by Orthosoft Inc (D/B/A Zimmer Cas)
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.