BioSphere Putty; BioSphere MIS Putty
K-Number: K241167 · 2024-12-20
ApplicantSynergy Biomedical
Decision Date2024-12-20
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
BioSphere Putty; BioSphere MIS Putty is a medical device manufactured by Synergy Biomedical. It received FDA 510(k) clearance on 2024-12-20 under approval number K241167. 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 Putty; BioSphere MIS Putty?
BioSphere Putty; BioSphere MIS Putty is a medical device that received FDA 510(k) clearance on 2024-12-20. It is manufactured by Synergy Biomedical. The 510(k) number is K241167.
When was BioSphere Putty; BioSphere MIS Putty approved by the FDA?
BioSphere Putty; BioSphere MIS Putty received FDA 510(k) clearance on 2024-12-20, under approval number K241167.
What company makes BioSphere Putty; BioSphere MIS Putty?
BioSphere Putty; BioSphere MIS Putty is manufactured by Synergy Biomedical.
What is the FDA product code for BioSphere Putty; BioSphere MIS Putty?
The FDA product code for BioSphere Putty; BioSphere MIS Putty is MQV.
Other Devices by Synergy Biomedical
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.