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FDA 510(k)

FITme Customized Silicone Implant

K-Number: K232593 · 2023-11-22

ApplicantKeosan Trading Co.
Decision Date2023-11-22
Product CodeFWP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

FITme Customized Silicone Implant is the device name listed in this FDA 510(k) record. The listed applicant is Keosan Trading Co.. It received FDA 510(k) clearance on 2023-11-22 under 510(k) number K232593. 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 FITme Customized Silicone Implant?

FITme Customized Silicone Implant is a medical device that received FDA 510(k) clearance on 2023-11-22. The listed applicant is Keosan Trading Co.. The 510(k) number is K232593.

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

FITme Customized Silicone Implant received FDA 510(k) clearance on 2023-11-22, under 510(k) number K232593.

Who is the listed applicant for FITme Customized Silicone Implant?

The FDA 510(k) record lists Keosan Trading Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FITme Customized Silicone Implant?

The FDA product code for FITme Customized Silicone Implant is FWP.

Other records listing Keosan Trading Co. 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.

K241150MISTI Silicone 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 KGK200610Customized Contour ImplantImplantech Associates, Inc.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

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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