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FZE — Prosthesis, Nose, Internal Class II

FDA Device Classification

Classification Details

Product Code
FZE
Device Class
Class II
Regulation Number
878.3680
Submission Type
Review Panel
SU
Medical Specialty
General, Plastic Surgery
Implant
Yes

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K241253cmf medicon surgicalMedicon Epiplating SystemDecember 12, 2024
K161548southern implants (pty)Osseointegrated FixturesDecember 1, 2016
K090803hanson medicalHANSON MEDICAL FACIAL IMPLANTSJune 30, 2010
K090630nobel biocareNOBEL BIOCARE ENDOSSEOUS IMPLANTS (MAXILLOFACIAL INDICATION)June 2, 2009
K071018hanson medicalMONARCH NASAL IMPLANTMay 25, 2007
K041690hanson medicalMONARCH NASAL IMPLANTFebruary 11, 2005
K021418aesthetic and reconstructive technologiesAART NASAL IMPLANTJuly 2, 2002
K992242pillar surgicalPILLAR NASAL, DORSAL COLUMELLA AND NASAL DORSUM IMPLANTSNovember 22, 1999
K983755surgical technology laboratoriesNASAL DORSAL SERIESNovember 20, 1998
K982753seare biomedicalSEARE BIOMEDICAL NASAL IMPLANTSSeptember 30, 1998
K981833silimedSILIMED NASAL L SHAPED IMPLANTJune 26, 1998
K973573hanson medicalDURALASTIC ANATOMICAL NASAL IMPLANTSNovember 13, 1997
K971481allied biomedicalDURALASTIC ANATOMICAL NASAL IMPLANTSJuly 18, 1997
K962824implantech associatesIMPLANTECH JEJ PERI-PYRIFORM IMPLANTOctober 3, 1996
K961124rand scientificTHE NAUTILUSApril 19, 1996
K952708spirit ridge technologiesPECTORALIS IMPLANTAugust 28, 1995
K952709spirit ridge technologiesPROTHESIS, CHIN, INTERNALAugust 28, 1995
K952705spirit ridge technologiesSPIRIT RIDGE NASAL IMPLANTAugust 28, 1995
K952707spirit ridge technologiesSILICONE ELASTOMER MALAR IMPLANTAugust 28, 1995
K952706spirit ridge technologiesSPIRIT RIDGE SILICONE CARVING BLOCKAugust 28, 1995