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FDA 510(k)

VersaWrap Nerve Protector

K-Number: K232029 · 2023-11-02

ApplicantAlafair Biosciences, Inc.
Decision Date2023-11-02
Product CodeJXI
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

VersaWrap Nerve 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 2023-11-02 under 510(k) number K232029. The device is classified under product code JXI. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VersaWrap Nerve Protector?

VersaWrap Nerve Protector is a medical device that received FDA 510(k) clearance on 2023-11-02. The listed applicant is Alafair Biosciences, Inc.. The 510(k) number is K232029.

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

VersaWrap Nerve Protector received FDA 510(k) clearance on 2023-11-02, under 510(k) number K232029.

Who is the listed applicant for VersaWrap Nerve 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 Nerve Protector?

The FDA product code for VersaWrap Nerve Protector is JXI.

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)K240817VersaWrapK213163VersaWrapK203600VersaWrap

View all 10 devices →

Related Devices (Code: JXI)

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.

K260245SILKBridgeKLISBio S.r.l.K253363NeuroSpan BridgeAuxilium Biotechnologies, Inc.K251505VersaCoat Nerve Protector (VTP-44G2); VersaCoat Nerve Protector (VTP-12G1)Alafair BiosciencesK251175VersaWrap Nerve Protector (VTP-2201); VersaWrap Nerve Protector (VTP-1201)Alafair BiosciencesK243889Remplir (ON-152, 15 x 20 mm); Remplir (ON-203, 20 x 30 mm); Remplir (ON-304, 30 x 40 mm); Remplir (ON-405, 40 x 50 mm)Orthocell, Ltd.K242113Nerve Wrap (07-DW-001-TAB)Biocircuit Technologies, Inc.

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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