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FDA 510(k)

METRONIC SOFAMOR DANEK CEMENT RESTRICTOR

K-Number: K011998 · 2001-07-26

ApplicantMedtronic Sofamor Danek, Inc.
Decision Date2001-07-26
Product CodeJDK
Advisory CommitteeSU
DecisionUnknown

Device Summary

METRONIC SOFAMOR DANEK CEMENT RESTRICTOR is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Sofamor Danek, Inc.. It received FDA 510(k) clearance on 2001-07-26 under 510(k) number K011998. The device is classified under product code JDK. It was reviewed by the SU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the METRONIC SOFAMOR DANEK CEMENT RESTRICTOR?

METRONIC SOFAMOR DANEK CEMENT RESTRICTOR is a medical device that received FDA 510(k) clearance on 2001-07-26. The listed applicant is Medtronic Sofamor Danek, Inc.. The 510(k) number is K011998.

When did METRONIC SOFAMOR DANEK CEMENT RESTRICTOR receive FDA 510(k) clearance?

METRONIC SOFAMOR DANEK CEMENT RESTRICTOR received FDA 510(k) clearance on 2001-07-26, under 510(k) number K011998.

Who is the listed applicant for METRONIC SOFAMOR DANEK CEMENT RESTRICTOR?

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

What is the FDA product code for METRONIC SOFAMOR DANEK CEMENT RESTRICTOR?

The FDA product code for METRONIC SOFAMOR DANEK CEMENT RESTRICTOR is JDK.

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Related Devices (Code: JDK)

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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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