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FDA 510(k)

HARRIS CEMENT RESTRICTOR

K-Number: K810353 · 1981-02-23

ApplicantCintor Orthopaedic Div.
Decision Date1981-02-23
Product CodeLZN
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

HARRIS CEMENT RESTRICTOR is the device name listed in this FDA 510(k) record. The listed applicant is Cintor Orthopaedic Div.. It received FDA 510(k) clearance on 1981-02-23 under 510(k) number K810353. 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 HARRIS CEMENT RESTRICTOR?

HARRIS CEMENT RESTRICTOR is a medical device that received FDA 510(k) clearance on 1981-02-23. The listed applicant is Cintor Orthopaedic Div.. The 510(k) number is K810353.

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

HARRIS CEMENT RESTRICTOR received FDA 510(k) clearance on 1981-02-23, under 510(k) number K810353.

Who is the listed applicant for HARRIS CEMENT RESTRICTOR?

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

What is the FDA product code for HARRIS CEMENT RESTRICTOR?

The FDA product code for HARRIS CEMENT RESTRICTOR is LZN.

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Other records listing Cintor Orthopaedic Div. 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.

K811451RADIAL HEAD PROSTHESISK810540KNEE PROSTHESISK803106AGINSKY NAILK803074FERNORAL HIP PROSTHESISK802627ORTRON 90* HIP PROSTHESISK802814ORTHOFIX AXIALEXTERNAL FIXATION SYS.

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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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