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FDA 510(k)

SPECTRUM DESIGNS BILATERAL GROOVE CHIN IMPLANT

K-Number: K980444 · 1998-05-06

ApplicantSpectrum Designs, Inc.
Decision Date1998-05-06
Product CodeFWP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SPECTRUM DESIGNS BILATERAL GROOVE CHIN IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Spectrum Designs, Inc.. It received FDA 510(k) clearance on 1998-05-06 under 510(k) number K980444. 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 SPECTRUM DESIGNS BILATERAL GROOVE CHIN IMPLANT?

SPECTRUM DESIGNS BILATERAL GROOVE CHIN IMPLANT is a medical device that received FDA 510(k) clearance on 1998-05-06. The listed applicant is Spectrum Designs, Inc.. The 510(k) number is K980444.

When did SPECTRUM DESIGNS BILATERAL GROOVE CHIN IMPLANT receive FDA 510(k) clearance?

SPECTRUM DESIGNS BILATERAL GROOVE CHIN IMPLANT received FDA 510(k) clearance on 1998-05-06, under 510(k) number K980444.

Who is the listed applicant for SPECTRUM DESIGNS BILATERAL GROOVE CHIN IMPLANT?

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

What is the FDA product code for SPECTRUM DESIGNS BILATERAL GROOVE CHIN IMPLANT?

The FDA product code for SPECTRUM DESIGNS BILATERAL GROOVE CHIN IMPLANT is FWP.

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Other records listing Spectrum Designs, 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.

K992522SPECTRUM DESIGNS SPECTRAGELK982688SPECTRUM DESIGNS PRE-FORM CONTOUR SILICONE CARVING BLOCKK980462SPECTRUM DESIGNS ANATOMICAL CHIN IMPLANTK980463SPECTRUM DESIGNS CURVILINEAR CHIN IMPLANTK980445SPECTRUM DESIGNS CONCAVE BACK CHIN IMPLANTK980446SPECTRUM DESIGNS ANTERIOR CHIN IMPLANT

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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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