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FDA 510(k)

IMPRO VISE ABSORBABLE CEMENT FLOW RESTRICTOR

K-Number: K011943 · 2001-09-19

ApplicantKensey Nash Corp.
Decision Date2001-09-19
Product CodeLZN
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

IMPRO VISE ABSORBABLE CEMENT FLOW RESTRICTOR is the device name listed in this FDA 510(k) record. The listed applicant is Kensey Nash Corp.. It received FDA 510(k) clearance on 2001-09-19 under 510(k) number K011943. 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 IMPRO VISE ABSORBABLE CEMENT FLOW RESTRICTOR?

IMPRO VISE ABSORBABLE CEMENT FLOW RESTRICTOR is a medical device that received FDA 510(k) clearance on 2001-09-19. The listed applicant is Kensey Nash Corp.. The 510(k) number is K011943.

When did IMPRO VISE ABSORBABLE CEMENT FLOW RESTRICTOR receive FDA 510(k) clearance?

IMPRO VISE ABSORBABLE CEMENT FLOW RESTRICTOR received FDA 510(k) clearance on 2001-09-19, under 510(k) number K011943.

Who is the listed applicant for IMPRO VISE ABSORBABLE CEMENT FLOW RESTRICTOR?

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

What is the FDA product code for IMPRO VISE ABSORBABLE CEMENT FLOW RESTRICTOR?

The FDA product code for IMPRO VISE ABSORBABLE CEMENT FLOW RESTRICTOR is LZN.

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Other records listing Kensey Nash 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.

K103787MEDEOR MATRIXK091192KENSEY NASH P1076 COLLAGEN DENTAL MEMBRANE, MODEL 20655-XXK091499MEDEOR MATRIX, MODELS 30010-XX (HYDRATED); 30020-XX (DRY)K090919KENSEY NASH FIBRILLAR COLLAGEN DENTAL MEMBRANEK073519QUICKCAT EXTRACTION CATHETER, MODEL 60090-01K071695KENSEY NASH MACROPORE SHIELD

View all 19 devices →

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.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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