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FDA 510(k)

PINNACLE REVISION SYSTEM

K-Number: K033338 · 2004-01-08

ApplicantDePuy Orthopaedics, Inc.
Decision Date2004-01-08
Product CodeLPH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PINNACLE REVISION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is DePuy Orthopaedics, Inc.. It received FDA 510(k) clearance on 2004-01-08 under 510(k) number K033338. The device is classified under product code LPH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PINNACLE REVISION SYSTEM?

PINNACLE REVISION SYSTEM is a medical device that received FDA 510(k) clearance on 2004-01-08. The listed applicant is DePuy Orthopaedics, Inc.. The 510(k) number is K033338.

When did PINNACLE REVISION SYSTEM receive FDA 510(k) clearance?

PINNACLE REVISION SYSTEM received FDA 510(k) clearance on 2004-01-08, under 510(k) number K033338.

Who is the listed applicant for PINNACLE REVISION SYSTEM?

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

What is the FDA product code for PINNACLE REVISION SYSTEM?

The FDA product code for PINNACLE REVISION SYSTEM is LPH.

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Other records listing DePuy Orthopaedics, Inc. as applicant

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Related Devices (Code: LPH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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