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FDA 510(k)

TOWNLEY TRANSFACETPEDICULAR SCREW FIXATION SYSTEM

K-Number: K003928 · 2001-01-17

ApplicantMedtronic Sofamor Danek, Inc.
Decision Date2001-01-17
Product CodeMRW
DecisionSubstantially Equivalent

Device Summary

TOWNLEY TRANSFACETPEDICULAR SCREW FIXATION 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 2001-01-17 under 510(k) number K003928. The device is classified under product code MRW. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TOWNLEY TRANSFACETPEDICULAR SCREW FIXATION SYSTEM?

TOWNLEY TRANSFACETPEDICULAR SCREW FIXATION SYSTEM is a medical device that received FDA 510(k) clearance on 2001-01-17. The listed applicant is Medtronic Sofamor Danek, Inc.. The 510(k) number is K003928.

When did TOWNLEY TRANSFACETPEDICULAR SCREW FIXATION SYSTEM receive FDA 510(k) clearance?

TOWNLEY TRANSFACETPEDICULAR SCREW FIXATION SYSTEM received FDA 510(k) clearance on 2001-01-17, under 510(k) number K003928.

Who is the listed applicant for TOWNLEY TRANSFACETPEDICULAR SCREW FIXATION 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 TOWNLEY TRANSFACETPEDICULAR SCREW FIXATION SYSTEM?

The FDA product code for TOWNLEY TRANSFACETPEDICULAR SCREW FIXATION SYSTEM is MRW.

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Related Devices (Code: MRW)

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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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