Gamma3 System
K-Number: K200869 · 2020-07-22
ApplicantStryker Trauma GmbH
Decision Date2020-07-22
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Gamma3 System is a medical device manufactured by Stryker Trauma GmbH. It received FDA 510(k) clearance on 2020-07-22 under approval number K200869. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Gamma3 System?
Gamma3 System is a medical device that received FDA 510(k) clearance on 2020-07-22. It is manufactured by Stryker Trauma GmbH. The 510(k) number is K200869.
When was Gamma3 System approved by the FDA?
Gamma3 System received FDA 510(k) clearance on 2020-07-22, under approval number K200869.
What company makes Gamma3 System?
Gamma3 System is manufactured by Stryker Trauma GmbH.
What is the FDA product code for Gamma3 System?
The FDA product code for Gamma3 System is HSB.
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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.