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FDA 510(k)

ZIMMER PLATES AND SCREWS SYSTEM SCREWS ONLY

K-Number: K112885 · 2011-12-19

ApplicantZimmer, Inc.
Decision Date2011-12-19
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ZIMMER PLATES AND SCREWS SYSTEM SCREWS ONLY is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer, Inc.. It received FDA 510(k) clearance on 2011-12-19 under 510(k) number K112885. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ZIMMER PLATES AND SCREWS SYSTEM SCREWS ONLY?

ZIMMER PLATES AND SCREWS SYSTEM SCREWS ONLY is a medical device that received FDA 510(k) clearance on 2011-12-19. The listed applicant is Zimmer, Inc.. The 510(k) number is K112885.

When did ZIMMER PLATES AND SCREWS SYSTEM SCREWS ONLY receive FDA 510(k) clearance?

ZIMMER PLATES AND SCREWS SYSTEM SCREWS ONLY received FDA 510(k) clearance on 2011-12-19, under 510(k) number K112885.

Who is the listed applicant for ZIMMER PLATES AND SCREWS SYSTEM SCREWS ONLY?

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 ZIMMER PLATES AND SCREWS SYSTEM SCREWS ONLY?

The FDA product code for ZIMMER PLATES AND SCREWS SYSTEM SCREWS ONLY is HWC. This falls under the Cardiovascular category.

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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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