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FDA 510(k)

IMPLEX CEMENT RESTRICTOR SYSTEM

K-Number: K943378 · 1994-09-23

ApplicantImplex Corp.
Decision Date1994-09-23
Product CodeLZN
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

IMPLEX CEMENT RESTRICTOR SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Implex Corp.. It received FDA 510(k) clearance on 1994-09-23 under 510(k) number K943378. 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 IMPLEX CEMENT RESTRICTOR SYSTEM?

IMPLEX CEMENT RESTRICTOR SYSTEM is a medical device that received FDA 510(k) clearance on 1994-09-23. The listed applicant is Implex Corp.. The 510(k) number is K943378.

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

IMPLEX CEMENT RESTRICTOR SYSTEM received FDA 510(k) clearance on 1994-09-23, under 510(k) number K943378.

Who is the listed applicant for IMPLEX CEMENT RESTRICTOR SYSTEM?

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

What is the FDA product code for IMPLEX CEMENT RESTRICTOR SYSTEM?

The FDA product code for IMPLEX CEMENT RESTRICTOR SYSTEM is LZN.

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Other records listing Implex Corp. 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.

K051978TRABECULAR METAL VERTEBRAL BODY REPLACEMENTK051196TRABECULAR METAL VERTEBRAL BODY REPLACEMENT, MODEL 06-165-011X1 AND 06-166-051X1K040487TRABECULAR METAL KNEE SYSTEM AUGMENTSK040630TRABECULAR METAL FEMORAL CONE AUGMENTS, MODEL 03-125-ZZZZK040756THE TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 10-340-XXXXXK031962NEXGEN TRABECULAR METAL TIBIAL CONE AUGMENTS

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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 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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