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FDA 510(k)

ANATOMICAL MANDIBULAR IMPLANT STYLE II

K-Number: K902827 · 1990-08-01

ApplicantImplantech Associates, Inc.
Decision Date1990-08-01
Product CodeFWP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ANATOMICAL MANDIBULAR IMPLANT STYLE II 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 1990-08-01 under 510(k) number K902827. 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 ANATOMICAL MANDIBULAR IMPLANT STYLE II?

ANATOMICAL MANDIBULAR IMPLANT STYLE II is a medical device that received FDA 510(k) clearance on 1990-08-01. The listed applicant is Implantech Associates, Inc.. The 510(k) number is K902827.

When did ANATOMICAL MANDIBULAR IMPLANT STYLE II receive FDA 510(k) clearance?

ANATOMICAL MANDIBULAR IMPLANT STYLE II received FDA 510(k) clearance on 1990-08-01, under 510(k) number K902827.

Who is the listed applicant for ANATOMICAL MANDIBULAR IMPLANT STYLE II?

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 ANATOMICAL MANDIBULAR IMPLANT STYLE II?

The FDA product code for ANATOMICAL MANDIBULAR IMPLANT STYLE II is FWP.

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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.

K200610Customized Contour ImplantK191130Customized Contour ImplantK172389ePTFE-Coated Auricular ImplantK071470IMPLANTECH EPTFE SHEETING, MODEL EPTFE-XXXK052504GLUTEAL IMPLANT, MODELS RND 5-X, TRD 6-XK052505CALF IMPLANT, MODEL EC17-X

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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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