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FDA 510(k)

Reinforced Flexible Collagen Nerve Cuff

K-Number: K170656 · 2017-06-01

ApplicantCollagen Matrix, Inc.
Decision Date2017-06-01
Product CodeJXI
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Reinforced Flexible Collagen Nerve Cuff is the device name listed in this FDA 510(k) record. The listed applicant is Collagen Matrix, Inc.. It received FDA 510(k) clearance on 2017-06-01 under 510(k) number K170656. 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 Reinforced Flexible Collagen Nerve Cuff?

Reinforced Flexible Collagen Nerve Cuff is a medical device that received FDA 510(k) clearance on 2017-06-01. The listed applicant is Collagen Matrix, Inc.. The 510(k) number is K170656.

When did Reinforced Flexible Collagen Nerve Cuff receive FDA 510(k) clearance?

Reinforced Flexible Collagen Nerve Cuff received FDA 510(k) clearance on 2017-06-01, under 510(k) number K170656.

Who is the listed applicant for Reinforced Flexible Collagen Nerve Cuff?

The FDA 510(k) record lists Collagen Matrix, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Reinforced Flexible Collagen Nerve Cuff?

The FDA product code for Reinforced Flexible Collagen Nerve Cuff is JXI.

Other records listing Collagen Matrix, Inc. as applicant

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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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