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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Alafair Biosciences, Inc.. It received FDA 510(k) clearance on 2016-06-10 under 510(k) 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. The listed applicant is Alafair Biosciences, Inc.. The 510(k) number is K160364.

When did VersaWrap Tendon Protector receive FDA 510(k) clearance?

VersaWrap Tendon Protector received FDA 510(k) clearance on 2016-06-10, under 510(k) number K160364.

Who is the listed applicant for VersaWrap Tendon Protector?

The FDA 510(k) record lists Alafair Biosciences, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VersaWrap Tendon Protector?

The FDA product code for VersaWrap Tendon Protector is OWW.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT04322370Prospective Randomized Blinded Trial of VersaWrap Tendon Protector for Zone 2 Flexor Tendon InjuriesCOMPLETED

Other records listing Alafair Biosciences, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251505VersaCoat Nerve Protector (VTP-44G2); VersaCoat Nerve Protector (VTP-12G1)K251655VersaCoat Tendon Protector (VTP-44G2); VersaCoat Tendon Protector (VTP-12G1)K251175VersaWrap Nerve Protector (VTP-2201); VersaWrap Nerve Protector (VTP-1201)K240817VersaWrapK232029VersaWrap Nerve ProtectorK213163VersaWrap

View all 10 devices →

Related Devices (Code: OWW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251655VersaCoat Tendon Protector (VTP-44G2); VersaCoat Tendon Protector (VTP-12G1)Alafair BiosciencesK250021RotiumNanofiber Solutions, LLCK242187BioBrace®Conmed CorporationK241906BioBrace® Reinforced ImplantConmed CorporationK240817VersaWrapAlafair Biosciences, Inc.K222220SpinMedix Absorbable Fibrous MembraneCelestray Biotech Company, LLC.,

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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