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FDA 510(k)

TORNIER CEMENT RESTRICTOR

K-Number: K061824 · 2006-09-14

ApplicantTornier
Decision Date2006-09-14
Product CodeLZN
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TORNIER CEMENT RESTRICTOR is the device name listed in this FDA 510(k) record. The listed applicant is Tornier. It received FDA 510(k) clearance on 2006-09-14 under 510(k) number K061824. 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 TORNIER CEMENT RESTRICTOR?

TORNIER CEMENT RESTRICTOR is a medical device that received FDA 510(k) clearance on 2006-09-14. The listed applicant is Tornier. The 510(k) number is K061824.

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

TORNIER CEMENT RESTRICTOR received FDA 510(k) clearance on 2006-09-14, under 510(k) number K061824.

Who is the listed applicant for TORNIER CEMENT RESTRICTOR?

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

What is the FDA product code for TORNIER CEMENT RESTRICTOR?

The FDA product code for TORNIER CEMENT RESTRICTOR is LZN.

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Other records listing Tornier as applicant

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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 OrthopaedicsK032685CEMSTOP CEMENT RESTRICTORTeknimed, S.A.K023680BIOBUCK 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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