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FDA 510(k)

INION GTR BIODEGRADABLE MEMBRANE SYSTEM

K-Number: K033074 · 2004-03-31

ApplicantInion , Ltd.
Decision Date2004-03-31
Product CodeNPK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

INION GTR BIODEGRADABLE MEMBRANE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Inion , Ltd.. It received FDA 510(k) clearance on 2004-03-31 under 510(k) number K033074. The device is classified under product code NPK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INION GTR BIODEGRADABLE MEMBRANE SYSTEM?

INION GTR BIODEGRADABLE MEMBRANE SYSTEM is a medical device that received FDA 510(k) clearance on 2004-03-31. The listed applicant is Inion , Ltd.. The 510(k) number is K033074.

When did INION GTR BIODEGRADABLE MEMBRANE SYSTEM receive FDA 510(k) clearance?

INION GTR BIODEGRADABLE MEMBRANE SYSTEM received FDA 510(k) clearance on 2004-03-31, under 510(k) number K033074.

Who is the listed applicant for INION GTR BIODEGRADABLE MEMBRANE SYSTEM?

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

What is the FDA product code for INION GTR BIODEGRADABLE MEMBRANE SYSTEM?

The FDA product code for INION GTR BIODEGRADABLE MEMBRANE SYSTEM is NPK.

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Other records listing Inion , Ltd. 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.

K071810INION SPINAL GRAFT CONTAINMENT SYSTEMK063410INION CPS/OTPS FREEDOMPLATEK062617MODIFICATION TO INION OTPS BIODEGRADABLE FIXATION SYSTEMK060393INION HEXALON BIODEGRADABLE ACL/PCL SCREWK051821INION S-1 BIODEGRADABLE ANTERIOR CERVICAL FUSION SYSTEMK052624INION OTPS BIODEGRADABLE DISTAL RADIUS PLATE

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Related Devices (Code: NPK)

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.

K221851Lumina-PTFE TitaniumCriteria Industria E Comercio DE Produtos MedicinaisK222549OpenTexPurgo Biologics, Inc.K211554InnoGenic Non-resorbable MembraneCowellmedi Co., Ltd.K210797Bio-MEM Ti Reinforced MembraneB&Medi Co., Ltd.K201187Cytoplast Titanium-Reinforced PTFE MembranesOsteogenics Biomedical, Inc.K171774RPM Reinforced PTFE MeshOsteogenics Biomedical, 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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