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FDA 510(k)

CEMENT RESTRICTOR FOR PROFORMA AND PERFECTA TOTAL

K-Number: K923909 · 1992-11-04

ApplicantOrthomet, Inc.
Decision Date1992-11-04
Product CodeLZN
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CEMENT RESTRICTOR FOR PROFORMA AND PERFECTA TOTAL is the device name listed in this FDA 510(k) record. The listed applicant is Orthomet, Inc.. It received FDA 510(k) clearance on 1992-11-04 under 510(k) number K923909. 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 CEMENT RESTRICTOR FOR PROFORMA AND PERFECTA TOTAL?

CEMENT RESTRICTOR FOR PROFORMA AND PERFECTA TOTAL is a medical device that received FDA 510(k) clearance on 1992-11-04. The listed applicant is Orthomet, Inc.. The 510(k) number is K923909.

When did CEMENT RESTRICTOR FOR PROFORMA AND PERFECTA TOTAL receive FDA 510(k) clearance?

CEMENT RESTRICTOR FOR PROFORMA AND PERFECTA TOTAL received FDA 510(k) clearance on 1992-11-04, under 510(k) number K923909.

Who is the listed applicant for CEMENT RESTRICTOR FOR PROFORMA AND PERFECTA TOTAL?

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

What is the FDA product code for CEMENT RESTRICTOR FOR PROFORMA AND PERFECTA TOTAL?

The FDA product code for CEMENT RESTRICTOR FOR PROFORMA AND PERFECTA TOTAL is LZN.

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Other records listing Orthomet, Inc. 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 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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