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FDA 510(k)

NEUROLAC NERVE GUIDE

K-Number: K050573 · 2005-05-04

ApplicantPolyganics B.V.,
Decision Date2005-05-04
Product CodeJXI
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NEUROLAC NERVE GUIDE is the device name listed in this FDA 510(k) record. The listed applicant is Polyganics B.V.,. It received FDA 510(k) clearance on 2005-05-04 under 510(k) number K050573. 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 NEUROLAC NERVE GUIDE?

NEUROLAC NERVE GUIDE is a medical device that received FDA 510(k) clearance on 2005-05-04. The listed applicant is Polyganics B.V.,. The 510(k) number is K050573.

When did NEUROLAC NERVE GUIDE receive FDA 510(k) clearance?

NEUROLAC NERVE GUIDE received FDA 510(k) clearance on 2005-05-04, under 510(k) number K050573.

Who is the listed applicant for NEUROLAC NERVE GUIDE?

The FDA 510(k) record lists Polyganics B.V., as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NEUROLAC NERVE GUIDE?

The FDA product code for NEUROLAC NERVE GUIDE is JXI.

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Other records listing Polyganics B.V., 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.

K112267NEUROLAC(R) NERVE GUIDEK070715NASOPORE EARK062540NASOPORE EAR, MODELS ND04, ND05K052099NASOPORE NASAL DRESSING, MODEL NDOX-YYY/ZZK042811VIVOSORB SHEET, MODEL FS01K032115NEUROLAC NERVE GUIDE MODELS NG01-15/03, NG01-020/03, NG01 025/03, NG01-030/03

View all 7 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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