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FDA 510(k)

MODIFICATION TO: LIGAFIX INTERFERENCE SCREW

K-Number: K070507 · 2007-03-29

ApplicantScience For Biomaterials
Decision Date2007-03-29
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO: LIGAFIX INTERFERENCE 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 2007-03-29 under 510(k) number K070507. 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 MODIFICATION TO: LIGAFIX INTERFERENCE SCREW?

MODIFICATION TO: LIGAFIX INTERFERENCE SCREW is a medical device that received FDA 510(k) clearance on 2007-03-29. The listed applicant is Science For Biomaterials. The 510(k) number is K070507.

When did MODIFICATION TO: LIGAFIX INTERFERENCE SCREW receive FDA 510(k) clearance?

MODIFICATION TO: LIGAFIX INTERFERENCE SCREW received FDA 510(k) clearance on 2007-03-29, under 510(k) number K070507.

Who is the listed applicant for MODIFICATION TO: LIGAFIX INTERFERENCE 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 MODIFICATION TO: LIGAFIX INTERFERENCE SCREW?

The FDA product code for MODIFICATION TO: LIGAFIX INTERFERENCE 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 PLUSK090994LIGAFIX INTERFACE SCREWK071155MODIFICATION TO: BIOSORB RESORBABLE VOID FILLERK061022BIO 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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