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FDA 510(k)

LIGAFIX RESORBABLE INTERFERENCE SCREW, MODELS 30 AND 60

K-Number: K050407 · 2005-11-04

ApplicantSciences For Bio Materials
Decision Date2005-11-04
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LIGAFIX RESORBABLE INTERFERENCE SCREW, MODELS 30 AND 60 is the device name listed in this FDA 510(k) record. The listed applicant is Sciences For Bio Materials. It received FDA 510(k) clearance on 2005-11-04 under 510(k) number K050407. 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 RESORBABLE INTERFERENCE SCREW, MODELS 30 AND 60?

LIGAFIX RESORBABLE INTERFERENCE SCREW, MODELS 30 AND 60 is a medical device that received FDA 510(k) clearance on 2005-11-04. The listed applicant is Sciences For Bio Materials. The 510(k) number is K050407.

When did LIGAFIX RESORBABLE INTERFERENCE SCREW, MODELS 30 AND 60 receive FDA 510(k) clearance?

LIGAFIX RESORBABLE INTERFERENCE SCREW, MODELS 30 AND 60 received FDA 510(k) clearance on 2005-11-04, under 510(k) number K050407.

Who is the listed applicant for LIGAFIX RESORBABLE INTERFERENCE SCREW, MODELS 30 AND 60?

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

What is the FDA product code for LIGAFIX RESORBABLE INTERFERENCE SCREW, MODELS 30 AND 60?

The FDA product code for LIGAFIX RESORBABLE INTERFERENCE SCREW, MODELS 30 AND 60 is HWC. This falls under the Cardiovascular category.

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Other records listing Sciences For Bio Materials 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.

K061262LIGAFIX INTERFERENCE SCREW

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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