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K Number
K981835
Device Name
SILIMED MALAR IMPLANT
Manufacturer
SILIMED, LLC.
Date Cleared
1998-07-09

(44 days)

Product Code
LZK
Regulation Number
878.3550
Type
Traditional
Panel
SU
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Silimed Malar Implant is designed to be used for augmentation and reconstruction of the cheek.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain the information requested regarding acceptance criteria, device performance, study details, and ground truth establishment for a medical device. The text is a 510(k) clearance letter from the FDA for a Malar Implant, primarily discussing the regulatory approval process and general regulations. It does not include specific performance metrics, clinical study designs, or expert review details.

§ 878.3550 Chin prosthesis.

(a)
Identification. A chin prosthesis is a silicone rubber solid device intended to be implanted to augment or reconstruct the chin.(b)
Classification. Class II.