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FDA 510(k)

MENISCUS CHIN IMPLANT

K-Number: K944164 · 1994-11-04

ApplicantSpectrum Designs, Inc.
Decision Date1994-11-04
Product CodeLZK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MENISCUS 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 1994-11-04 under 510(k) number K944164. 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 MENISCUS CHIN IMPLANT?

MENISCUS CHIN IMPLANT is a medical device that received FDA 510(k) clearance on 1994-11-04. The listed applicant is Spectrum Designs, Inc.. The 510(k) number is K944164.

When did MENISCUS CHIN IMPLANT receive FDA 510(k) clearance?

MENISCUS CHIN IMPLANT received FDA 510(k) clearance on 1994-11-04, under 510(k) number K944164.

Who is the listed applicant for MENISCUS 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 MENISCUS CHIN IMPLANT?

The FDA product code for MENISCUS CHIN 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 BLOCKK980444SPECTRUM DESIGNS BILATERAL GROOVE CHIN IMPLANTK980463SPECTRUM DESIGNS CURVILINEAR CHIN IMPLANTK980445SPECTRUM DESIGNS CONCAVE BACK CHIN IMPLANTK980446SPECTRUM DESIGNS ANTERIOR 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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