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FDA 510(k)

LEVTECH BONE SCREW

K-Number: K901144 · 1990-10-10

ApplicantLevtech, Inc.
Decision Date1990-10-10
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LEVTECH BONE SCREW is the device name listed in this FDA 510(k) record. The listed applicant is Levtech, Inc.. It received FDA 510(k) clearance on 1990-10-10 under 510(k) number K901144. 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 LEVTECH BONE SCREW?

LEVTECH BONE SCREW is a medical device that received FDA 510(k) clearance on 1990-10-10. The listed applicant is Levtech, Inc.. The 510(k) number is K901144.

When did LEVTECH BONE SCREW receive FDA 510(k) clearance?

LEVTECH BONE SCREW received FDA 510(k) clearance on 1990-10-10, under 510(k) number K901144.

Who is the listed applicant for LEVTECH BONE SCREW?

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

What is the FDA product code for LEVTECH BONE SCREW?

The FDA product code for LEVTECH BONE SCREW is HWC. This falls under the Cardiovascular category.

Related Clinical Trials

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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Other records listing Levtech, 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.

K910128LEVTECH TITANIUM BONE WIREK873693LEVTECH COMPOSITE TRACTION TONGSK874023LEVTECH CLAMP APPLIERK850039HALIFAX SPINAL CLAMP

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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