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FDA 510(k)

LINK CEMENT PLUG

K-Number: K972411 · 1997-08-29

ApplicantTurnkey Intergration USA, Inc.
Decision Date1997-08-29
Product CodeLZN
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LINK CEMENT PLUG is the device name listed in this FDA 510(k) record. The listed applicant is Turnkey Intergration USA, Inc.. It received FDA 510(k) clearance on 1997-08-29 under 510(k) number K972411. 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 LINK CEMENT PLUG?

LINK CEMENT PLUG is a medical device that received FDA 510(k) clearance on 1997-08-29. The listed applicant is Turnkey Intergration USA, Inc.. The 510(k) number is K972411.

When did LINK CEMENT PLUG receive FDA 510(k) clearance?

LINK CEMENT PLUG received FDA 510(k) clearance on 1997-08-29, under 510(k) number K972411.

Who is the listed applicant for LINK CEMENT PLUG?

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

What is the FDA product code for LINK CEMENT PLUG?

The FDA product code for LINK CEMENT PLUG is LZN.

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Other records listing Turnkey Intergration USA, Inc. 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.

K991405OMNI-FIX, HUMERAL NAILK990523B2C, ESPACE REVISION CUP SYSTEMK990307OMNI-FIX, NAIL SYSTEMK970284ARTOS, DIPLOS SYSTEMK970084LINK CERCLAGE WIRE SYSTEMK953653LUBINUS SP II HIP SYSTEM

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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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