Bio2 CLM BG Bioactive Scaffold
K-Number: K152589 · 2016-01-12
ApplicantBio2 Technologies, Inc.
Decision Date2016-01-12
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Bio2 CLM BG Bioactive Scaffold is a medical device manufactured by Bio2 Technologies, Inc.. It received FDA 510(k) clearance on 2016-01-12 under approval number K152589. 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 Bio2 CLM BG Bioactive Scaffold?
Bio2 CLM BG Bioactive Scaffold is a medical device that received FDA 510(k) clearance on 2016-01-12. It is manufactured by Bio2 Technologies, Inc.. The 510(k) number is K152589.
When was Bio2 CLM BG Bioactive Scaffold approved by the FDA?
Bio2 CLM BG Bioactive Scaffold received FDA 510(k) clearance on 2016-01-12, under approval number K152589.
What company makes Bio2 CLM BG Bioactive Scaffold?
Bio2 CLM BG Bioactive Scaffold is manufactured by Bio2 Technologies, Inc..
What is the FDA product code for Bio2 CLM BG Bioactive Scaffold?
The FDA product code for Bio2 CLM BG Bioactive Scaffold 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.