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FDA 510(k)

STRYKER CMF MEDPOR CUSTOMIZED IMPLANT

K-Number: K121315 · 2012-11-01

ApplicantHowmedica Osteonics Corp.
Decision Date2012-11-01
Product CodeFWP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

STRYKER CMF MEDPOR CUSTOMIZED IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Osteonics Corp.. It received FDA 510(k) clearance on 2012-11-01 under 510(k) number K121315. The device is classified under product code FWP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STRYKER CMF MEDPOR CUSTOMIZED IMPLANT?

STRYKER CMF MEDPOR CUSTOMIZED IMPLANT is a medical device that received FDA 510(k) clearance on 2012-11-01. The listed applicant is Howmedica Osteonics Corp.. The 510(k) number is K121315.

When did STRYKER CMF MEDPOR CUSTOMIZED IMPLANT receive FDA 510(k) clearance?

STRYKER CMF MEDPOR CUSTOMIZED IMPLANT received FDA 510(k) clearance on 2012-11-01, under 510(k) number K121315.

Who is the listed applicant for STRYKER CMF MEDPOR CUSTOMIZED IMPLANT?

The FDA 510(k) record lists Howmedica Osteonics Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STRYKER CMF MEDPOR CUSTOMIZED IMPLANT?

The FDA product code for STRYKER CMF MEDPOR CUSTOMIZED IMPLANT is FWP.

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Other records listing Howmedica Osteonics Corp. as applicant

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Related Devices (Code: FWP)

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.

K254233MEDPOR Customized Implant KitStryker Leibinger GmbH & Co KGK232593FITme Customized Silicone ImplantKeosan Trading Co.K200610Customized Contour ImplantImplantech Associates, Inc.K191130Customized Contour ImplantImplantech Associates, Inc.K191916Stryker CMF MEDPOR Priority Customized Implant KitStryker Leibinger GmbH & Co KGK153508Stryker CMF MEDPOR Customized ImplantStryker

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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