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FDA 510(k)

INION HEXALON BIODEGRADABLE ACL/PCL SCREW

K-Number: K071464 · 2007-08-03

ApplicantInion OY
Decision Date2007-08-03
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

INION HEXALON BIODEGRADABLE ACL/PCL SCREW is the device name listed in this FDA 510(k) record. The listed applicant is Inion OY. It received FDA 510(k) clearance on 2007-08-03 under 510(k) number K071464. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INION HEXALON BIODEGRADABLE ACL/PCL SCREW?

INION HEXALON BIODEGRADABLE ACL/PCL SCREW is a medical device that received FDA 510(k) clearance on 2007-08-03. The listed applicant is Inion OY. The 510(k) number is K071464.

When did INION HEXALON BIODEGRADABLE ACL/PCL SCREW receive FDA 510(k) clearance?

INION HEXALON BIODEGRADABLE ACL/PCL SCREW received FDA 510(k) clearance on 2007-08-03, under 510(k) number K071464.

Who is the listed applicant for INION HEXALON BIODEGRADABLE ACL/PCL SCREW?

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

What is the FDA product code for INION HEXALON BIODEGRADABLE ACL/PCL SCREW?

The FDA product code for INION HEXALON BIODEGRADABLE ACL/PCL SCREW is HWC. This falls under the Cardiovascular category.

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Other records listing Inion OY 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.

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Related Devices (Code: HWC)

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.

K262975Arthrex Beaming SystemArthrex, Inc.K260995DynaNail Helix® Fixation SystemMedShape, Inc.K254280F.A.S.T ScrewSteps OrthoK261057ActivaScrew™ Cannulated COMBioretec, Ltd.K260106OsteoCoil™ GT Active Compression SystemFlower Orthopedics Corporation DBA Conventus Flower OrthopedK262344Large Compression ScrewsTriMed, 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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