VersaWrap Tendon Protector

Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon

Alafair Biosciences Inc

The following data is part of a premarket notification filed by Alafair Biosciences Inc with the FDA for Versawrap Tendon Protector.

Pre-market Notification Details

Device IDK160364
510k NumberK160364
Device Name:VersaWrap Tendon Protector
ClassificationMesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon
Applicant Alafair Biosciences Inc 3925 W. Braker Lane, Floor #3 Austin,  TX  78759
ContactBen Walthall
CorrespondentBen Walthall
Alafair Biosciences Inc 3925 W. Braker Lane, Floor #3 Austin,  TX  78759
Product CodeOWW  
CFR Regulation Number878.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-02-09
Decision Date2016-06-10
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
B454VTP22010 K160364 000

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