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FDA 510(k)

OSTEONICS UNIVERSAL DISTAL CEMENT PLUG

K-Number: K992462 · 1999-08-13

ApplicantHowmedica Osteonics Corp.
Decision Date1999-08-13
Product CodeLZN
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

OSTEONICS UNIVERSAL DISTAL CEMENT PLUG is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Osteonics Corp.. It received FDA 510(k) clearance on 1999-08-13 under 510(k) number K992462. 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 OSTEONICS UNIVERSAL DISTAL CEMENT PLUG?

OSTEONICS UNIVERSAL DISTAL CEMENT PLUG is a medical device that received FDA 510(k) clearance on 1999-08-13. The listed applicant is Howmedica Osteonics Corp.. The 510(k) number is K992462.

When did OSTEONICS UNIVERSAL DISTAL CEMENT PLUG receive FDA 510(k) clearance?

OSTEONICS UNIVERSAL DISTAL CEMENT PLUG received FDA 510(k) clearance on 1999-08-13, under 510(k) number K992462.

Who is the listed applicant for OSTEONICS UNIVERSAL DISTAL CEMENT PLUG?

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

What is the FDA product code for OSTEONICS UNIVERSAL DISTAL CEMENT PLUG?

The FDA product code for OSTEONICS UNIVERSAL DISTAL CEMENT PLUG is LZN.

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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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