ADAPT for Gamma3
K-Number: K173946 · 2018-05-02
ApplicantStryker GmbH
Decision Date2018-05-02
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
ADAPT for Gamma3 is a medical device manufactured by Stryker GmbH. It received FDA 510(k) clearance on 2018-05-02 under approval number K173946. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ADAPT for Gamma3?
ADAPT for Gamma3 is a medical device that received FDA 510(k) clearance on 2018-05-02. It is manufactured by Stryker GmbH. The 510(k) number is K173946.
When was ADAPT for Gamma3 approved by the FDA?
ADAPT for Gamma3 received FDA 510(k) clearance on 2018-05-02, under approval number K173946.
What company makes ADAPT for Gamma3?
ADAPT for Gamma3 is manufactured by Stryker GmbH.
What is the FDA product code for ADAPT for Gamma3?
The FDA product code for ADAPT for Gamma3 is OLO.
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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.