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FDA 510(k)

CEMSTOP CEMENT RESTRICTOR

K-Number: K032685 · 2003-11-26

ApplicantTeknimed, S.A.
Decision Date2003-11-26
Product CodeLZN
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CEMSTOP CEMENT RESTRICTOR is the device name listed in this FDA 510(k) record. The listed applicant is Teknimed, S.A.. It received FDA 510(k) clearance on 2003-11-26 under 510(k) number K032685. 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 CEMSTOP CEMENT RESTRICTOR?

CEMSTOP CEMENT RESTRICTOR is a medical device that received FDA 510(k) clearance on 2003-11-26. The listed applicant is Teknimed, S.A.. The 510(k) number is K032685.

When did CEMSTOP CEMENT RESTRICTOR receive FDA 510(k) clearance?

CEMSTOP CEMENT RESTRICTOR received FDA 510(k) clearance on 2003-11-26, under 510(k) number K032685.

Who is the listed applicant for CEMSTOP CEMENT RESTRICTOR?

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

What is the FDA product code for CEMSTOP CEMENT RESTRICTOR?

The FDA product code for CEMSTOP CEMENT RESTRICTOR is LZN.

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Other records listing Teknimed, S.A. 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.

K103433F20K090435VERTECEMK083005NANGELK080873OPACITY + BONE CEMENTK062102ODONCERK043593SPINE-FIX BIOMIMETIC BONE CEMENT

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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 RESTRICTORTornierK023680BIOBUCK CEMENT RESTRICTORSmith & Nephew, Inc.K011943IMPRO VISE ABSORBABLE CEMENT FLOW RESTRICTORKensey Nash Corp.K010840SYNPLUGIsotis NVK000587SHUTTLE STOPIsotis 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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