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FDA 510(k)

NEURA WRAP NERVE PROTECTOR

K-Number: K041620 · 2004-07-16

ApplicantIntegra Lifesciences Corp.
Decision Date2004-07-16
Product CodeJXI
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NEURA WRAP NERVE PROTECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Integra Lifesciences Corp.. It received FDA 510(k) clearance on 2004-07-16 under 510(k) number K041620. 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 NEURA WRAP NERVE PROTECTOR?

NEURA WRAP NERVE PROTECTOR is a medical device that received FDA 510(k) clearance on 2004-07-16. The listed applicant is Integra Lifesciences Corp.. The 510(k) number is K041620.

When did NEURA WRAP NERVE PROTECTOR receive FDA 510(k) clearance?

NEURA WRAP NERVE PROTECTOR received FDA 510(k) clearance on 2004-07-16, under 510(k) number K041620.

Who is the listed applicant for NEURA WRAP NERVE PROTECTOR?

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

What is the FDA product code for NEURA WRAP NERVE PROTECTOR?

The FDA product code for NEURA WRAP NERVE PROTECTOR is JXI.

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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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