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FDA 510(k)

THREADED CEMENT RESTRICTOR (CR) TITANIUM

K-Number: K011443 · 2001-08-03

ApplicantMedtronic Sofamor Danek USA, Inc.
Decision Date2001-08-03
Product CodeJDK
Advisory CommitteeSU
DecisionUnknown

Device Summary

THREADED CEMENT RESTRICTOR (CR) TITANIUM is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Sofamor Danek USA, Inc.. It received FDA 510(k) clearance on 2001-08-03 under 510(k) number K011443. 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 THREADED CEMENT RESTRICTOR (CR) TITANIUM?

THREADED CEMENT RESTRICTOR (CR) TITANIUM is a medical device that received FDA 510(k) clearance on 2001-08-03. The listed applicant is Medtronic Sofamor Danek USA, Inc.. The 510(k) number is K011443.

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

THREADED CEMENT RESTRICTOR (CR) TITANIUM received FDA 510(k) clearance on 2001-08-03, under 510(k) number K011443.

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

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

What is the FDA product code for THREADED CEMENT RESTRICTOR (CR) TITANIUM?

The FDA product code for THREADED CEMENT RESTRICTOR (CR) TITANIUM is JDK.

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Related Devices (Code: JDK)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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