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FDA 510(k)

BLOCK CEMENT RESTRICTOR (CR) - TITANIUM

K-Number: K013014 · 2001-10-04

ApplicantMedtronic Sofamor Danek, Inc.
Decision Date2001-10-04
Product CodeJDK
Advisory CommitteeSU
DecisionUnknown

Device Summary

BLOCK CEMENT RESTRICTOR (CR) - TITANIUM 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 2001-10-04 under 510(k) number K013014. 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 BLOCK CEMENT RESTRICTOR (CR) - TITANIUM?

BLOCK CEMENT RESTRICTOR (CR) - TITANIUM is a medical device that received FDA 510(k) clearance on 2001-10-04. The listed applicant is Medtronic Sofamor Danek, Inc.. The 510(k) number is K013014.

When did BLOCK CEMENT RESTRICTOR (CR) - TITANIUM receive FDA 510(k) clearance?

BLOCK CEMENT RESTRICTOR (CR) - TITANIUM received FDA 510(k) clearance on 2001-10-04, under 510(k) number K013014.

Who is the listed applicant for BLOCK CEMENT RESTRICTOR (CR) - TITANIUM?

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 BLOCK CEMENT RESTRICTOR (CR) - TITANIUM?

The FDA product code for BLOCK CEMENT RESTRICTOR (CR) - TITANIUM is 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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