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FDA 510(k)

PYRAMID +4 ANTERIOR LUMBAR SPINE PLATE SYSTEM

K-Number: K071416 · 2007-11-01

ApplicantMedtronic Sofamor Danek USA, Inc.
Decision Date2007-11-01
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PYRAMID +4 ANTERIOR LUMBAR SPINE PLATE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Sofamor Danek USA, Inc.. It received FDA 510(k) clearance on 2007-11-01 under 510(k) number K071416. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PYRAMID +4 ANTERIOR LUMBAR SPINE PLATE SYSTEM?

PYRAMID +4 ANTERIOR LUMBAR SPINE PLATE SYSTEM is a medical device that received FDA 510(k) clearance on 2007-11-01. The listed applicant is Medtronic Sofamor Danek USA, Inc.. The 510(k) number is K071416.

When did PYRAMID +4 ANTERIOR LUMBAR SPINE PLATE SYSTEM receive FDA 510(k) clearance?

PYRAMID +4 ANTERIOR LUMBAR SPINE PLATE SYSTEM received FDA 510(k) clearance on 2007-11-01, under 510(k) number K071416.

Who is the listed applicant for PYRAMID +4 ANTERIOR LUMBAR SPINE PLATE SYSTEM?

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

What is the FDA product code for PYRAMID +4 ANTERIOR LUMBAR SPINE PLATE SYSTEM?

The FDA product code for PYRAMID +4 ANTERIOR LUMBAR SPINE PLATE SYSTEM is KWQ.

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Related Devices (Code: KWQ)

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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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