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FDA 510(k)

BIOSTOP G BONE CEMENT RESTRICTOR

K-Number: K943727 · 1995-05-11

ApplicantLandos, Inc.
Decision Date1995-05-11
Product CodeLZN
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BIOSTOP G BONE CEMENT RESTRICTOR is the device name listed in this FDA 510(k) record. The listed applicant is Landos, Inc.. It received FDA 510(k) clearance on 1995-05-11 under 510(k) number K943727. 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 BIOSTOP G BONE CEMENT RESTRICTOR?

BIOSTOP G BONE CEMENT RESTRICTOR is a medical device that received FDA 510(k) clearance on 1995-05-11. The listed applicant is Landos, Inc.. The 510(k) number is K943727.

When did BIOSTOP G BONE CEMENT RESTRICTOR receive FDA 510(k) clearance?

BIOSTOP G BONE CEMENT RESTRICTOR received FDA 510(k) clearance on 1995-05-11, under 510(k) number K943727.

Who is the listed applicant for BIOSTOP G BONE CEMENT RESTRICTOR?

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

What is the FDA product code for BIOSTOP G BONE CEMENT RESTRICTOR?

The FDA product code for BIOSTOP G BONE CEMENT RESTRICTOR is LZN.

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Other records listing Landos, Inc. as applicant

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K964226MEMORY STAPLE (20 SIZES AVAILABLE)K97106834MM SCARF THREAD-HEAD(TM) SCREWK971070SCARF THREAD-HEAD (TM) HEAD SCREWK971069TWIST-OFF (TM) SCREWK961732KARK97084622.2/+4MM CO CR & ZIRCONIA FEMORAL HEAD

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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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