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FDA 510(k)

SPECTRUM DESIGNS PROFILE MALAR IMPLANT

K-Number: K980139 · 1998-03-03

ApplicantSpectrum Designs, Inc.
Decision Date1998-03-03
Product CodeLZK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SPECTRUM DESIGNS PROFILE MALAR 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 1998-03-03 under 510(k) number K980139. The device is classified under product code LZK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPECTRUM DESIGNS PROFILE MALAR IMPLANT?

SPECTRUM DESIGNS PROFILE MALAR IMPLANT is a medical device that received FDA 510(k) clearance on 1998-03-03. The listed applicant is Spectrum Designs, Inc.. The 510(k) number is K980139.

When did SPECTRUM DESIGNS PROFILE MALAR IMPLANT receive FDA 510(k) clearance?

SPECTRUM DESIGNS PROFILE MALAR IMPLANT received FDA 510(k) clearance on 1998-03-03, under 510(k) number K980139.

Who is the listed applicant for SPECTRUM DESIGNS PROFILE MALAR 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 PROFILE MALAR IMPLANT?

The FDA product code for SPECTRUM DESIGNS PROFILE MALAR IMPLANT is LZK.

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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 BLOCKK980446SPECTRUM DESIGNS ANTERIOR CHIN IMPLANTK980445SPECTRUM DESIGNS CONCAVE BACK CHIN IMPLANTK980444SPECTRUM DESIGNS BILATERAL GROOVE CHIN IMPLANTK980463SPECTRUM DESIGNS CURVILINEAR CHIN IMPLANT

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Related Devices (Code: LZK)

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.

K021419AART MALAR IMPLANTAesthetic and Reconstructive Technologies, Inc.K002886IMPLANTECH COMPOSITE FACIAL IMPLANTS (MALAR, CHIN, AND NASAL)Implantech Associates, Inc.K992240PILLAR MALAR IMPLANTPillar Surgical, Inc.K983756SURGIFORM ANATOMICAL MALARSurgical Technology Laboratories, Inc.K982763SEARE BIOMEDICAL MALAR IMPLANTSSeare Biomedical Corp.K981835SILIMED MALAR IMPLANTSilimed, 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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