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FDA 510(k)

MODIFICATON TO: PYRAMID +4 ANTERIOR LUMBAR PLATE SYSTEM

K-Number: K080429 · 2008-04-30

ApplicantMedtronic Sofamor Danek USA, Inc.
Decision Date2008-04-30
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MODIFICATON TO: PYRAMID +4 ANTERIOR LUMBAR 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 2008-04-30 under 510(k) number K080429. 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 MODIFICATON TO: PYRAMID +4 ANTERIOR LUMBAR PLATE SYSTEM?

MODIFICATON TO: PYRAMID +4 ANTERIOR LUMBAR PLATE SYSTEM is a medical device that received FDA 510(k) clearance on 2008-04-30. The listed applicant is Medtronic Sofamor Danek USA, Inc.. The 510(k) number is K080429.

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

MODIFICATON TO: PYRAMID +4 ANTERIOR LUMBAR PLATE SYSTEM received FDA 510(k) clearance on 2008-04-30, under 510(k) number K080429.

Who is the listed applicant for MODIFICATON TO: PYRAMID +4 ANTERIOR LUMBAR 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 MODIFICATON TO: PYRAMID +4 ANTERIOR LUMBAR PLATE SYSTEM?

The FDA product code for MODIFICATON TO: PYRAMID +4 ANTERIOR LUMBAR PLATE SYSTEM is 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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