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FDA 510(k)

TRIABSORB COMPOSITE SCREW

K-Number: K050468 · 2005-08-31

ApplicantAdvanced Biomaterials
Decision Date2005-08-31
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TRIABSORB COMPOSITE SCREW is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Biomaterials. It received FDA 510(k) clearance on 2005-08-31 under 510(k) number K050468. 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 TRIABSORB COMPOSITE SCREW?

TRIABSORB COMPOSITE SCREW is a medical device that received FDA 510(k) clearance on 2005-08-31. The listed applicant is Advanced Biomaterials. The 510(k) number is K050468.

When did TRIABSORB COMPOSITE SCREW receive FDA 510(k) clearance?

TRIABSORB COMPOSITE SCREW received FDA 510(k) clearance on 2005-08-31, under 510(k) number K050468.

Who is the listed applicant for TRIABSORB COMPOSITE SCREW?

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

What is the FDA product code for TRIABSORB COMPOSITE SCREW?

The FDA product code for TRIABSORB COMPOSITE SCREW is HWC. This falls under the Cardiovascular category.

Related Clinical Trials

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Other records listing Advanced 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.

K032830PLLA CANNULATED INTERFERENCE SCREWK033749TITANIUM CANNULATED 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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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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