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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 a medical device manufactured by Alafair Biosciences. It received FDA 510(k) clearance on 2025-07-18 under approval 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. It is manufactured by Alafair Biosciences. The 510(k) number is K251655.

When was VersaCoat Tendon Protector (VTP-44G2); VersaCoat Tendon Protector (VTP-12G1) approved by the FDA?

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

What company makes VersaCoat Tendon Protector (VTP-44G2); VersaCoat Tendon Protector (VTP-12G1)?

VersaCoat Tendon Protector (VTP-44G2); VersaCoat Tendon Protector (VTP-12G1) is manufactured by Alafair Biosciences.

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 Devices by Alafair Biosciences

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

Related Devices (Code: OWW)

K160364VersaWrap Tendon ProtectorAlafair Biosciences, Inc. K203267The BioBrace ImplantBiorez, Inc. K222220SpinMedix Absorbable Fibrous MembraneCelestray Biotech Company, LLC., K230316FlexBand; FlexPatch; FlexBand PlusInternational Life Sciences K242187BioBrace®Conmed Corporation K241906BioBrace® Reinforced ImplantConmed Corporation

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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