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FDA 510(k)

COVAORTHO-NERVE RESORBABLE COLLAGEN MEMBRANE

K-Number: K103081 · 2012-03-02

ApplicantBiom'Up Sas
Decision Date2012-03-02
Product CodeJXI
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

COVAORTHO-NERVE RESORBABLE COLLAGEN MEMBRANE is the device name listed in this FDA 510(k) record. The listed applicant is Biom'Up Sas. It received FDA 510(k) clearance on 2012-03-02 under 510(k) number K103081. 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 COVAORTHO-NERVE RESORBABLE COLLAGEN MEMBRANE?

COVAORTHO-NERVE RESORBABLE COLLAGEN MEMBRANE is a medical device that received FDA 510(k) clearance on 2012-03-02. The listed applicant is Biom'Up Sas. The 510(k) number is K103081.

When did COVAORTHO-NERVE RESORBABLE COLLAGEN MEMBRANE receive FDA 510(k) clearance?

COVAORTHO-NERVE RESORBABLE COLLAGEN MEMBRANE received FDA 510(k) clearance on 2012-03-02, under 510(k) number K103081.

Who is the listed applicant for COVAORTHO-NERVE RESORBABLE COLLAGEN MEMBRANE?

The FDA 510(k) record lists Biom'Up Sas as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COVAORTHO-NERVE RESORBABLE COLLAGEN MEMBRANE?

The FDA product code for COVAORTHO-NERVE RESORBABLE COLLAGEN MEMBRANE is JXI.

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Other records listing Biom'Up Sas 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.

K103087COVAMAX RESORBABLE COLLAGEN MEMBRANE

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

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

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