JGH1 Bone Graft Substitute
K-Number: K181342 · 2018-07-19
ApplicantAgNovos Healthcare USA, LLC
Decision Date2018-07-19
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
JGH1 Bone Graft Substitute is a medical device manufactured by AgNovos Healthcare USA, LLC. It received FDA 510(k) clearance on 2018-07-19 under approval number K181342. The device is classified under product code MQV. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the JGH1 Bone Graft Substitute?
JGH1 Bone Graft Substitute is a medical device that received FDA 510(k) clearance on 2018-07-19. It is manufactured by AgNovos Healthcare USA, LLC. The 510(k) number is K181342.
When was JGH1 Bone Graft Substitute approved by the FDA?
JGH1 Bone Graft Substitute received FDA 510(k) clearance on 2018-07-19, under approval number K181342.
What company makes JGH1 Bone Graft Substitute?
JGH1 Bone Graft Substitute is manufactured by AgNovos Healthcare USA, LLC.
What is the FDA product code for JGH1 Bone Graft Substitute?
The FDA product code for JGH1 Bone Graft Substitute is MQV.
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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.