FDA 510(k)

NERBRIDGE

K-Number: K152967 · 2016-06-22

Decision Date2016-06-22

Product CodeJXI

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

NERBRIDGE is the device name listed in this FDA 510(k) record. The listed applicant is Toyobo Co., Ltd.. It received FDA 510(k) clearance on 2016-06-22 under 510(k) number K152967. 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 NERBRIDGE?

NERBRIDGE is a medical device that received FDA 510(k) clearance on 2016-06-22. The listed applicant is Toyobo Co., Ltd.. The 510(k) number is K152967.

When did NERBRIDGE receive FDA 510(k) clearance?

NERBRIDGE received FDA 510(k) clearance on 2016-06-22, under 510(k) number K152967.

Who is the listed applicant for NERBRIDGE?

The FDA 510(k) record lists Toyobo Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NERBRIDGE?

The FDA product code for NERBRIDGE is JXI.

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 Biosciences K251175VersaWrap Nerve Protector (VTP-2201); VersaWrap Nerve Protector (VTP-1201)Alafair Biosciences K243889Remplir (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

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