VersaWrap Tendon Protector
K-Number: K200311 · 2020-03-06
ApplicantAlafair Biosciences, Inc.
Decision Date2020-03-06
Product CodeFTM
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
VersaWrap Tendon Protector is a medical device manufactured by Alafair Biosciences, Inc.. It received FDA 510(k) clearance on 2020-03-06 under approval number K200311. The device is classified under product code FTM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the VersaWrap Tendon Protector?
VersaWrap Tendon Protector is a medical device that received FDA 510(k) clearance on 2020-03-06. It is manufactured by Alafair Biosciences, Inc.. The 510(k) number is K200311.
When was VersaWrap Tendon Protector approved by the FDA?
VersaWrap Tendon Protector received FDA 510(k) clearance on 2020-03-06, under approval number K200311.
What company makes VersaWrap Tendon Protector?
VersaWrap Tendon Protector is manufactured by Alafair Biosciences, Inc..
What is the FDA product code for VersaWrap Tendon Protector?
The FDA product code for VersaWrap Tendon Protector is FTM.
Other Devices by Alafair Biosciences, Inc.
Related Devices (Code: FTM)
K162461Endoform Plastics and Reconstructive MatrixAroa Biosurgery (Formerly Mesynthes Limited)
K162554Gentrix Surgical MatrixAcell, Inc.
K160181COLORADO THERAPEUTICS XENOGRAFT IMPLANTColorado Therapeutics, LLC
K161221Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula PlugCook Biotech Incorporated
K160869Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair GraftCook Biotech Incorporated
K153633Endoform Reconstructive TemplateAroa Biosurgery Limited (Formerly Mesynthes Limited)
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.