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FDA 510(k)

TSRH SPINAL SYSTEM

K-Number: K982990 · 1998-10-21

ApplicantSofamor Danek USA,Inc.
Decision Date1998-10-21
Product CodeMNI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TSRH SPINAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Sofamor Danek USA,Inc.. It received FDA 510(k) clearance on 1998-10-21 under 510(k) number K982990. 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 TSRH SPINAL SYSTEM?

TSRH SPINAL SYSTEM is a medical device that received FDA 510(k) clearance on 1998-10-21. The listed applicant is Sofamor Danek USA,Inc.. The 510(k) number is K982990.

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

TSRH SPINAL SYSTEM received FDA 510(k) clearance on 1998-10-21, under 510(k) number K982990.

Who is the listed applicant for TSRH SPINAL SYSTEM?

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

What is the FDA product code for TSRH SPINAL SYSTEM?

The FDA product code for TSRH SPINAL SYSTEM is MNI.

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Other records listing Sofamor Danek USA,Inc. as applicant

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Related Devices (Code: 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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