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FDA 510(k)

LEVTECH TITANIUM BONE WIRE

K-Number: K910128 · 1991-06-18

ApplicantLevtech, Inc.
Decision Date1991-06-18
Product CodeJDQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LEVTECH TITANIUM BONE WIRE is the device name listed in this FDA 510(k) record. The listed applicant is Levtech, Inc.. It received FDA 510(k) clearance on 1991-06-18 under 510(k) number K910128. The device is classified under product code JDQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LEVTECH TITANIUM BONE WIRE?

LEVTECH TITANIUM BONE WIRE is a medical device that received FDA 510(k) clearance on 1991-06-18. The listed applicant is Levtech, Inc.. The 510(k) number is K910128.

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

LEVTECH TITANIUM BONE WIRE received FDA 510(k) clearance on 1991-06-18, under 510(k) number K910128.

Who is the listed applicant for LEVTECH TITANIUM BONE WIRE?

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 TITANIUM BONE WIRE?

The FDA product code for LEVTECH TITANIUM BONE WIRE is JDQ.

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.

K901144LEVTECH BONE SCREWK873693LEVTECH COMPOSITE TRACTION TONGSK874023LEVTECH CLAMP APPLIERK850039HALIFAX SPINAL CLAMP

Related Devices (Code: JDQ)

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.

K261271Cable-Ready® Cable Grip SystemPioneer Surgical Technology, Inc.K243905Stitch Cerclage – Suture TapesGM Dos Reis Industria e Comercio Ltda.K243344Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage SuturesArthrex, Inc.K232733Mbrace CableMedacta International S.A.K233949ACCORD Cable SystemSmith & Nephew, Inc.K232986VariTrax Sternal CircumFixation SystemCircumfix Solutions, 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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