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FDA 510(k)

PERIARTICULAR LOCKING PLATES AND SCREWS, SERIES 2358 AND 2359

K-Number: K043560 · 2005-01-21

ApplicantZimmer, Inc.
Decision Date2005-01-21
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PERIARTICULAR LOCKING PLATES AND SCREWS, SERIES 2358 AND 2359 is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer, Inc.. It received FDA 510(k) clearance on 2005-01-21 under 510(k) number K043560. 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 AND SCREWS, SERIES 2358 AND 2359?

PERIARTICULAR LOCKING PLATES AND SCREWS, SERIES 2358 AND 2359 is a medical device that received FDA 510(k) clearance on 2005-01-21. The listed applicant is Zimmer, Inc.. The 510(k) number is K043560.

When did PERIARTICULAR LOCKING PLATES AND SCREWS, SERIES 2358 AND 2359 receive FDA 510(k) clearance?

PERIARTICULAR LOCKING PLATES AND SCREWS, SERIES 2358 AND 2359 received FDA 510(k) clearance on 2005-01-21, under 510(k) number K043560.

Who is the listed applicant for PERIARTICULAR LOCKING PLATES AND SCREWS, SERIES 2358 AND 2359?

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 AND SCREWS, SERIES 2358 AND 2359?

The FDA product code for PERIARTICULAR LOCKING PLATES AND SCREWS, SERIES 2358 AND 2359 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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