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FDA 510(k)

ARTHREX CANNULATED INTERFERENCE SCREW

K-Number: K915424 · 1993-02-09

ApplicantArthrex, Inc.
Decision Date1993-02-09
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ARTHREX CANNULATED INTERFERENCE SCREW is the device name listed in this FDA 510(k) record. The listed applicant is Arthrex, Inc.. It received FDA 510(k) clearance on 1993-02-09 under 510(k) number K915424. 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 ARTHREX CANNULATED INTERFERENCE SCREW?

ARTHREX CANNULATED INTERFERENCE SCREW is a medical device that received FDA 510(k) clearance on 1993-02-09. The listed applicant is Arthrex, Inc.. The 510(k) number is K915424.

When did ARTHREX CANNULATED INTERFERENCE SCREW receive FDA 510(k) clearance?

ARTHREX CANNULATED INTERFERENCE SCREW received FDA 510(k) clearance on 1993-02-09, under 510(k) number K915424.

Who is the listed applicant for ARTHREX CANNULATED INTERFERENCE SCREW?

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

What is the FDA product code for ARTHREX CANNULATED INTERFERENCE SCREW?

The FDA product code for ARTHREX CANNULATED INTERFERENCE SCREW is HWC. This falls under the Cardiovascular category.

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Other records listing Arthrex, Inc. 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.

K262975Arthrex Beaming SystemK262618Arthrex Spine Compression FT ScrewK262451Arthrex DynaNite StaplesK262357Arthrex Bioabsorbable PushLock Suture AnchorsK260624Arthrex Radial Head Replacement SystemK260018Arthrex FiberButton

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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

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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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