VersaWrap Nerve Protector
K-Number: K201631 · 2020-09-14
ApplicantAlafair Biosciences, Inc.
Decision Date2020-09-14
Product CodeJXI
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
VersaWrap Nerve Protector is a medical device manufactured by Alafair Biosciences, Inc.. It received FDA 510(k) clearance on 2020-09-14 under approval number K201631. The device is classified under product code JXI. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the VersaWrap Nerve Protector?
VersaWrap Nerve Protector is a medical device that received FDA 510(k) clearance on 2020-09-14. It is manufactured by Alafair Biosciences, Inc.. The 510(k) number is K201631.
When was VersaWrap Nerve Protector approved by the FDA?
VersaWrap Nerve Protector received FDA 510(k) clearance on 2020-09-14, under approval number K201631.
What company makes VersaWrap Nerve Protector?
VersaWrap Nerve Protector is manufactured by Alafair Biosciences, Inc..
What is the FDA product code for VersaWrap Nerve Protector?
The FDA product code for VersaWrap Nerve Protector is JXI.
Related Clinical Trials
Other Devices by Alafair Biosciences, Inc.
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K163457NeuraGen 3D Nerve Guide MatrixIntegra LifeSciences Corporation
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.