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FDA 510(k)

SPINAL MESH SYSTEM

K-Number: K011406 · 2001-12-27

ApplicantMedtronic Sofamor Danek, Inc.
Decision Date2001-12-27
Product CodeMQP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SPINAL MESH 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 2001-12-27 under 510(k) number K011406. The device is classified under product code MQP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPINAL MESH SYSTEM?

SPINAL MESH SYSTEM is a medical device that received FDA 510(k) clearance on 2001-12-27. The listed applicant is Medtronic Sofamor Danek, Inc.. The 510(k) number is K011406.

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

SPINAL MESH SYSTEM received FDA 510(k) clearance on 2001-12-27, under 510(k) number K011406.

Who is the listed applicant for SPINAL MESH 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 SPINAL MESH SYSTEM?

The FDA product code for SPINAL MESH SYSTEM is MQP.

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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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