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FDA 510(k)

PERIARTICULAR LOCKING PLATES, 2358 SERIES

K-Number: K043227 · 2004-12-10

ApplicantZimmer, Inc.
Decision Date2004-12-10
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PERIARTICULAR LOCKING PLATES, 2358 SERIES is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer, Inc.. It received FDA 510(k) clearance on 2004-12-10 under 510(k) number K043227. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PERIARTICULAR LOCKING PLATES, 2358 SERIES?

PERIARTICULAR LOCKING PLATES, 2358 SERIES is a medical device that received FDA 510(k) clearance on 2004-12-10. The listed applicant is Zimmer, Inc.. The 510(k) number is K043227.

When did PERIARTICULAR LOCKING PLATES, 2358 SERIES receive FDA 510(k) clearance?

PERIARTICULAR LOCKING PLATES, 2358 SERIES received FDA 510(k) clearance on 2004-12-10, under 510(k) number K043227.

Who is the listed applicant for PERIARTICULAR LOCKING PLATES, 2358 SERIES?

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

What is the FDA product code for PERIARTICULAR LOCKING PLATES, 2358 SERIES?

The FDA product code for PERIARTICULAR LOCKING PLATES, 2358 SERIES is HRS.

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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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