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FDA 510(k)

MODIFICATION TO TSRH SPINAL SYSTEM

K-Number: K030285 · 2003-02-25

ApplicantMedtronic Sofamor Danek, Inc.
Decision Date2003-02-25
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO TSRH SPINAL SYSTEM 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 2003-02-25 under 510(k) number K030285. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO TSRH SPINAL SYSTEM?

MODIFICATION TO TSRH SPINAL SYSTEM is a medical device that received FDA 510(k) clearance on 2003-02-25. The listed applicant is Medtronic Sofamor Danek, Inc.. The 510(k) number is K030285.

When did MODIFICATION TO TSRH SPINAL SYSTEM receive FDA 510(k) clearance?

MODIFICATION TO TSRH SPINAL SYSTEM received FDA 510(k) clearance on 2003-02-25, under 510(k) number K030285.

Who is the listed applicant for MODIFICATION TO TSRH SPINAL SYSTEM?

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 MODIFICATION TO TSRH SPINAL SYSTEM?

The FDA product code for MODIFICATION TO TSRH SPINAL SYSTEM is NKB.

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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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