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FDA 510(k)

ACUFEX TIBIAL ANCHOR SCREW & SPIKED WASHER

K-Number: K961649 · 1996-07-16

ApplicantSmith & Nephew Endoscopy, Inc.
Decision Date1996-07-16
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

ACUFEX TIBIAL ANCHOR SCREW & SPIKED WASHER is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew Endoscopy, Inc.. It received FDA 510(k) clearance on 1996-07-16 under 510(k) number K961649. 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 for Some Indications.

Frequently Asked Questions

What is the ACUFEX TIBIAL ANCHOR SCREW & SPIKED WASHER?

ACUFEX TIBIAL ANCHOR SCREW & SPIKED WASHER is a medical device that received FDA 510(k) clearance on 1996-07-16. The listed applicant is Smith & Nephew Endoscopy, Inc.. The 510(k) number is K961649.

When did ACUFEX TIBIAL ANCHOR SCREW & SPIKED WASHER receive FDA 510(k) clearance?

ACUFEX TIBIAL ANCHOR SCREW & SPIKED WASHER received FDA 510(k) clearance on 1996-07-16, under 510(k) number K961649.

Who is the listed applicant for ACUFEX TIBIAL ANCHOR SCREW & SPIKED WASHER?

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

What is the FDA product code for ACUFEX TIBIAL ANCHOR SCREW & SPIKED WASHER?

The FDA product code for ACUFEX TIBIAL ANCHOR SCREW & SPIKED WASHER is HWC. This falls under the Cardiovascular category.

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Other records listing Smith & Nephew Endoscopy, 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.

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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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