SIGNAFUSE Bioactive Bone Graft
K-Number: K193513 · 2020-06-18
ApplicantBioventus
Decision Date2020-06-18
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
SIGNAFUSE Bioactive Bone Graft is a medical device manufactured by Bioventus. It received FDA 510(k) clearance on 2020-06-18 under approval number K193513. 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 SIGNAFUSE Bioactive Bone Graft?
SIGNAFUSE Bioactive Bone Graft is a medical device that received FDA 510(k) clearance on 2020-06-18. It is manufactured by Bioventus. The 510(k) number is K193513.
When was SIGNAFUSE Bioactive Bone Graft approved by the FDA?
SIGNAFUSE Bioactive Bone Graft received FDA 510(k) clearance on 2020-06-18, under approval number K193513.
What company makes SIGNAFUSE Bioactive Bone Graft?
SIGNAFUSE Bioactive Bone Graft is manufactured by Bioventus.
What is the FDA product code for SIGNAFUSE Bioactive Bone Graft?
The FDA product code for SIGNAFUSE Bioactive Bone Graft is MQV.
Related Devices (Code: MQV)
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.