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FDA 510(k)

ALANTECH GRAFT FIXATION SCREW

K-Number: K031937 · 2003-09-04

ApplicantArthrocare Corp.
Decision Date2003-09-04
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ALANTECH GRAFT FIXATION SCREW is the device name listed in this FDA 510(k) record. The listed applicant is Arthrocare Corp.. It received FDA 510(k) clearance on 2003-09-04 under 510(k) number K031937. 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 ALANTECH GRAFT FIXATION SCREW?

ALANTECH GRAFT FIXATION SCREW is a medical device that received FDA 510(k) clearance on 2003-09-04. The listed applicant is Arthrocare Corp.. The 510(k) number is K031937.

When did ALANTECH GRAFT FIXATION SCREW receive FDA 510(k) clearance?

ALANTECH GRAFT FIXATION SCREW received FDA 510(k) clearance on 2003-09-04, under 510(k) number K031937.

Who is the listed applicant for ALANTECH GRAFT FIXATION SCREW?

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

What is the FDA product code for ALANTECH GRAFT FIXATION SCREW?

The FDA product code for ALANTECH GRAFT FIXATION SCREW is HWC. This falls under the Cardiovascular category.

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Other records listing Arthrocare Corp. as applicant

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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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