Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by Implantech Associates, Inc.. It received FDA 510(k) clearance on 2020-12-23 under approval 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. It is manufactured by Implantech Associates, Inc.. The 510(k) number is K200610.

When was Customized Contour Implant approved by the FDA?

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

What company makes Customized Contour Implant?

Customized Contour Implant is manufactured by Implantech Associates, Inc..

What is the FDA product code for Customized Contour Implant?

The FDA product code for Customized Contour Implant is FWP.

Related Clinical Trials

NCT05362370 Stryker PEEK Customized Implant: A Prospective Post Market Follow Up to Evaluate Safety, Performance and Effectiveness ACTIVE_NOT_RECRUITING NCT07580495 Effect of Collagen Membrane on Ridge Preservation NOT_YET_RECRUITING NCT07492576 Evaluation of the Magnesium Shield Compared to Dual Zone Grafting Approach in Immediate Implant Site Management RECRUITING

Other Devices by Implantech Associates, Inc.

K172389ePTFE-Coated Auricular Implant K191130Customized Contour Implant

Related Devices (Code: FWP)

K153508Stryker CMF MEDPOR Customized ImplantStryker K152463SU-POR Patient-Specific Cranial Implant, SU-POR Patient-Specific Facial ImplantPoriferous, LLC K191130Customized Contour ImplantImplantech Associates, Inc. K191916Stryker CMF MEDPOR Priority Customized Implant KitStryker Leibinger GmbH & Co KG K232593FITme Customized Silicone ImplantKeosan Trading Co. K254233MEDPOR Customized Implant KitStryker Leibinger GmbH & Co KG

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.

↑