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FDA 510(k)

THE UNIVERSAL CEMENT PLUG(TM)

K-Number: K910135 · 1991-03-05

ApplicantBiotron , Ltd.
Decision Date1991-03-05
Product CodeLZN
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

THE UNIVERSAL CEMENT PLUG(TM) is the device name listed in this FDA 510(k) record. The listed applicant is Biotron , Ltd.. It received FDA 510(k) clearance on 1991-03-05 under 510(k) number K910135. The device is classified under product code LZN. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE UNIVERSAL CEMENT PLUG(TM)?

THE UNIVERSAL CEMENT PLUG(TM) is a medical device that received FDA 510(k) clearance on 1991-03-05. The listed applicant is Biotron , Ltd.. The 510(k) number is K910135.

When did THE UNIVERSAL CEMENT PLUG(TM) receive FDA 510(k) clearance?

THE UNIVERSAL CEMENT PLUG(TM) received FDA 510(k) clearance on 1991-03-05, under 510(k) number K910135.

Who is the listed applicant for THE UNIVERSAL CEMENT PLUG(TM)?

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

What is the FDA product code for THE UNIVERSAL CEMENT PLUG(TM)?

The FDA product code for THE UNIVERSAL CEMENT PLUG(TM) is LZN.

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 Biotron , Ltd. 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.

K843583FIRM-A-TRON MARK XK810634FIRM-A-TRONK780802ARMTROL AND FERMTROLK780803TILL-U-TEST, DIP SLIDE

Related Devices (Code: LZN)

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.

K220838Artisan Bone Plug, Universal Cement RestrictorHowmedica Osteonics, Dba Stryker OrthopaedicsK061824TORNIER CEMENT RESTRICTORTornierK032685CEMSTOP CEMENT RESTRICTORTeknimed, S.A.K023680BIOBUCK CEMENT RESTRICTORSmith & Nephew, Inc.K011943IMPRO VISE ABSORBABLE CEMENT FLOW RESTRICTORKensey Nash Corp.K010840SYNPLUGIsotis NV

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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