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FDA 510(k)

DYNALOK CLASSIC SPINAL SYSTEM

K-Number: K033271 · 2003-11-06

ApplicantMedtronic Sofamor Danek
Decision Date2003-11-06
Product CodeMNI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DYNALOK CLASSIC SPINAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Sofamor Danek. It received FDA 510(k) clearance on 2003-11-06 under 510(k) number K033271. The device is classified under product code MNI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DYNALOK CLASSIC SPINAL SYSTEM?

DYNALOK CLASSIC SPINAL SYSTEM is a medical device that received FDA 510(k) clearance on 2003-11-06. The listed applicant is Medtronic Sofamor Danek. The 510(k) number is K033271.

When did DYNALOK CLASSIC SPINAL SYSTEM receive FDA 510(k) clearance?

DYNALOK CLASSIC SPINAL SYSTEM received FDA 510(k) clearance on 2003-11-06, under 510(k) number K033271.

Who is the listed applicant for DYNALOK CLASSIC SPINAL SYSTEM?

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

What is the FDA product code for DYNALOK CLASSIC SPINAL SYSTEM?

The FDA product code for DYNALOK CLASSIC SPINAL SYSTEM is MNI.

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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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