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FDA 510(k)

AEGIS ANTERIOR LUMBAR PLATE SYSTEM

K-Number: K052546 · 2006-02-03

ApplicantDepuy Spine, Inc.
Decision Date2006-02-03
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AEGIS ANTERIOR LUMBAR PLATE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Depuy Spine, Inc.. It received FDA 510(k) clearance on 2006-02-03 under 510(k) number K052546. 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 AEGIS ANTERIOR LUMBAR PLATE SYSTEM?

AEGIS ANTERIOR LUMBAR PLATE SYSTEM is a medical device that received FDA 510(k) clearance on 2006-02-03. The listed applicant is Depuy Spine, Inc.. The 510(k) number is K052546.

When did AEGIS ANTERIOR LUMBAR PLATE SYSTEM receive FDA 510(k) clearance?

AEGIS ANTERIOR LUMBAR PLATE SYSTEM received FDA 510(k) clearance on 2006-02-03, under 510(k) number K052546.

Who is the listed applicant for AEGIS ANTERIOR LUMBAR PLATE SYSTEM?

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

What is the FDA product code for AEGIS ANTERIOR LUMBAR PLATE SYSTEM?

The FDA product code for AEGIS ANTERIOR LUMBAR PLATE SYSTEM is KWQ.

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Other records listing Depuy Spine, Inc. as applicant

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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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