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FDA 510(k)

34MM SCARF THREAD-HEAD(TM) SCREW

K-Number: K971068 · 1997-07-09

ApplicantLandos, Inc.
Decision Date1997-07-09
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

34MM SCARF THREAD-HEAD(TM) SCREW is the device name listed in this FDA 510(k) record. The listed applicant is Landos, Inc.. It received FDA 510(k) clearance on 1997-07-09 under 510(k) number K971068. 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 34MM SCARF THREAD-HEAD(TM) SCREW?

34MM SCARF THREAD-HEAD(TM) SCREW is a medical device that received FDA 510(k) clearance on 1997-07-09. The listed applicant is Landos, Inc.. The 510(k) number is K971068.

When did 34MM SCARF THREAD-HEAD(TM) SCREW receive FDA 510(k) clearance?

34MM SCARF THREAD-HEAD(TM) SCREW received FDA 510(k) clearance on 1997-07-09, under 510(k) number K971068.

Who is the listed applicant for 34MM SCARF THREAD-HEAD(TM) SCREW?

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

What is the FDA product code for 34MM SCARF THREAD-HEAD(TM) SCREW?

The FDA product code for 34MM SCARF THREAD-HEAD(TM) SCREW is HWC. This falls under the Cardiovascular category.

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Other records listing Landos, 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.

K964226MEMORY STAPLE (20 SIZES AVAILABLE)K971069TWIST-OFF (TM) SCREWK971070SCARF THREAD-HEAD (TM) HEAD SCREWK961732KARK97084622.2/+4MM CO CR & ZIRCONIA FEMORAL HEADK953111CORAIL

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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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