BioSphere MIS Putty (BioSphere MIS)
K-Number: K173301 · 2018-01-19
ApplicantSynergy Biomedical, LLC
Decision Date2018-01-19
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
BioSphere MIS Putty (BioSphere MIS) is a medical device manufactured by Synergy Biomedical, LLC. It received FDA 510(k) clearance on 2018-01-19 under approval number K173301. 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 BioSphere MIS Putty (BioSphere MIS)?
BioSphere MIS Putty (BioSphere MIS) is a medical device that received FDA 510(k) clearance on 2018-01-19. It is manufactured by Synergy Biomedical, LLC. The 510(k) number is K173301.
When was BioSphere MIS Putty (BioSphere MIS) approved by the FDA?
BioSphere MIS Putty (BioSphere MIS) received FDA 510(k) clearance on 2018-01-19, under approval number K173301.
What company makes BioSphere MIS Putty (BioSphere MIS)?
BioSphere MIS Putty (BioSphere MIS) is manufactured by Synergy Biomedical, LLC.
What is the FDA product code for BioSphere MIS Putty (BioSphere MIS)?
The FDA product code for BioSphere MIS Putty (BioSphere MIS) 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.