Orthoss(R)
K-Number: K190754 · 2019-06-23
ApplicantGeistlich Pharma AG
Decision Date2019-06-23
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Orthoss(R) is a medical device manufactured by Geistlich Pharma AG. It received FDA 510(k) clearance on 2019-06-23 under approval number K190754. 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 Orthoss(R)?
Orthoss(R) is a medical device that received FDA 510(k) clearance on 2019-06-23. It is manufactured by Geistlich Pharma AG. The 510(k) number is K190754.
When was Orthoss(R) approved by the FDA?
Orthoss(R) received FDA 510(k) clearance on 2019-06-23, under approval number K190754.
What company makes Orthoss(R)?
Orthoss(R) is manufactured by Geistlich Pharma AG.
What is the FDA product code for Orthoss(R)?
The FDA product code for Orthoss(R) 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.