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FDA 510(k)

LIGAFIX INTERFACE SCREW

K-Number: K090994 · 2009-05-06

ApplicantScience For Biomaterials
Decision Date2009-05-06
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LIGAFIX INTERFACE SCREW is the device name listed in this FDA 510(k) record. The listed applicant is Science For Biomaterials. It received FDA 510(k) clearance on 2009-05-06 under 510(k) number K090994. 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 LIGAFIX INTERFACE SCREW?

LIGAFIX INTERFACE SCREW is a medical device that received FDA 510(k) clearance on 2009-05-06. The listed applicant is Science For Biomaterials. The 510(k) number is K090994.

When did LIGAFIX INTERFACE SCREW receive FDA 510(k) clearance?

LIGAFIX INTERFACE SCREW received FDA 510(k) clearance on 2009-05-06, under 510(k) number K090994.

Who is the listed applicant for LIGAFIX INTERFACE SCREW?

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

What is the FDA product code for LIGAFIX INTERFACE SCREW?

The FDA product code for LIGAFIX INTERFACE SCREW is HWC. This falls under the Cardiovascular category.

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Other records listing Science For Biomaterials 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.

K120818OTIS-C PLUSK071155MODIFICATION TO: BIOSORB RESORBABLE VOID FILLERK070507MODIFICATION TO: LIGAFIX INTERFERENCE SCREWK061022BIO 1-KIT BIOSORB FILLED CARTRIDGE

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

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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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