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FDA 510(k)

LIMA CEMENT RESTRICTOR

K-Number: K911338 · 1991-06-28

ApplicantTurnkey Intergration USA, Inc.
Decision Date1991-06-28
Product CodeJDK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LIMA CEMENT RESTRICTOR 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 1991-06-28 under 510(k) number K911338. The device is classified under product code JDK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIMA CEMENT RESTRICTOR?

LIMA CEMENT RESTRICTOR is a medical device that received FDA 510(k) clearance on 1991-06-28. The listed applicant is Turnkey Intergration USA, Inc.. The 510(k) number is K911338.

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

LIMA CEMENT RESTRICTOR received FDA 510(k) clearance on 1991-06-28, under 510(k) number K911338.

Who is the listed applicant for LIMA CEMENT RESTRICTOR?

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 LIMA CEMENT RESTRICTOR?

The FDA product code for LIMA CEMENT RESTRICTOR is JDK.

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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 SYSTEMK972411LINK CEMENT PLUGK970284ARTOS, DIPLOS SYSTEMK970084LINK CERCLAGE WIRE SYSTEM

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Related Devices (Code: JDK)

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.

K210062Mectaplug PE IIMedacta International S.A.K061465KMI CEMENT RESTRICTOR IMPLANTKinetikos Medical, Inc.K061698MODIFICATION TO LIFE SPINE CEMENT RESTRICTORLife SpineK060247LIFE SPINE CEMENT RESTRICTORLife SpineK060132SPINAL USA CEMENT RESTRICTOR SYSTEMSpinal USAK051371INTERBODY INNOVATIONS CEMENT RESTRICTORInterbody Innovations, Llp

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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