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FDA 510(k)

VersaCoat Tendon Protector (VTP-44G2); VersaCoat Tendon Protector (VTP-12G1)

K-Number: K251655 · 2025-07-18

ApplicantAlafair Biosciences
Decision Date2025-07-18
Product CodeOWW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

VersaCoat Tendon Protector (VTP-44G2); VersaCoat Tendon Protector (VTP-12G1) is the device name listed in this FDA 510(k) record. The listed applicant is Alafair Biosciences. It received FDA 510(k) clearance on 2025-07-18 under 510(k) number K251655. 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 VersaCoat Tendon Protector (VTP-44G2); VersaCoat Tendon Protector (VTP-12G1)?

VersaCoat Tendon Protector (VTP-44G2); VersaCoat Tendon Protector (VTP-12G1) is a medical device that received FDA 510(k) clearance on 2025-07-18. The listed applicant is Alafair Biosciences. The 510(k) number is K251655.

When did VersaCoat Tendon Protector (VTP-44G2); VersaCoat Tendon Protector (VTP-12G1) receive FDA 510(k) clearance?

VersaCoat Tendon Protector (VTP-44G2); VersaCoat Tendon Protector (VTP-12G1) received FDA 510(k) clearance on 2025-07-18, under 510(k) number K251655.

Who is the listed applicant for VersaCoat Tendon Protector (VTP-44G2); VersaCoat Tendon Protector (VTP-12G1)?

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

What is the FDA product code for VersaCoat Tendon Protector (VTP-44G2); VersaCoat Tendon Protector (VTP-12G1)?

The FDA product code for VersaCoat Tendon Protector (VTP-44G2); VersaCoat Tendon Protector (VTP-12G1) is OWW.

Other records listing Alafair Biosciences 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)K251175VersaWrap Nerve Protector (VTP-2201); VersaWrap Nerve Protector (VTP-1201)K240817VersaWrapK232029VersaWrap Nerve ProtectorK213163VersaWrapK203600VersaWrap

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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.

K250021RotiumNanofiber Solutions, LLCK242187BioBrace®Conmed CorporationK241906BioBrace® Reinforced ImplantConmed CorporationK240817VersaWrapAlafair Biosciences, Inc.K222220SpinMedix Absorbable Fibrous MembraneCelestray Biotech Company, LLC.,K230316FlexBand; FlexPatch; FlexBand PlusInternational Life Sciences

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.

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