VersaWrap Tendon Protector
K-Number: K160364 · 2016-06-10
ApplicantAlafair Biosciences, Inc.
Decision Date2016-06-10
Product CodeOWW
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 2016-06-10 under approval number K160364. The device is classified under product code OWW. 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 2016-06-10. It is manufactured by Alafair Biosciences, Inc.. The 510(k) number is K160364.
When was VersaWrap Tendon Protector approved by the FDA?
VersaWrap Tendon Protector received FDA 510(k) clearance on 2016-06-10, under approval number K160364.
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 OWW.
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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.