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FDA 510(k)

Customized Contour Implant

K-Number: K200610 · 2020-12-23

ApplicantImplantech Associates, Inc.
Decision Date2020-12-23
Product CodeFWP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Customized Contour Implant is the device name listed in this FDA 510(k) record. The listed applicant is Implantech Associates, Inc.. It received FDA 510(k) clearance on 2020-12-23 under 510(k) number K200610. 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 Customized Contour Implant?

Customized Contour Implant is a medical device that received FDA 510(k) clearance on 2020-12-23. The listed applicant is Implantech Associates, Inc.. The 510(k) number is K200610.

When did Customized Contour Implant receive FDA 510(k) clearance?

Customized Contour Implant received FDA 510(k) clearance on 2020-12-23, under 510(k) number K200610.

Who is the listed applicant for Customized Contour Implant?

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

What is the FDA product code for Customized Contour Implant?

The FDA product code for Customized Contour Implant is FWP.

Other records listing Implantech Associates, Inc. as applicant

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.

K191130Customized Contour ImplantK172389ePTFE-Coated Auricular Implant

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.K191130Customized Contour ImplantImplantech Associates, Inc.K191916Stryker CMF MEDPOR Priority Customized Implant KitStryker Leibinger GmbH & Co KGK153508Stryker CMF MEDPOR Customized ImplantStrykerK152463SU-POR Patient-Specific Cranial Implant, SU-POR Patient-Specific Facial ImplantPoriferous, LLC

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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