FDA 510(k) Applications for Medical Device Product Code "FZE"
(Prosthesis, Nose, Internal)

FDA 510(k) Number Applicant Device Name Decision Date
K021418 AESTHETIC AND RECONSTRUCTIVE TECHNOLOGIES, INC. AART NASAL IMPLANT 07/02/2002
K971481 ALLIED BIOMEDICAL CORP. DURALASTIC ANATOMICAL NASAL IMPLANTS 07/18/1997
K973573 HANSON MEDICAL, INC. DURALASTIC ANATOMICAL NASAL IMPLANTS 11/13/1997
K090803 HANSON MEDICAL, INC. HANSON MEDICAL FACIAL IMPLANTS 06/30/2010
K041690 HANSON MEDICAL, INC. MONARCH NASAL IMPLANT 02/11/2005
K071018 HANSON MEDICAL, INC. MONARCH NASAL IMPLANT 05/25/2007
K962824 IMPLANTECH ASSOCIATES, INC. IMPLANTECH JEJ PERI-PYRIFORM IMPLANT 10/03/1996
K090630 NOBEL BIOCARE AB NOBEL BIOCARE ENDOSSEOUS IMPLANTS (MAXILLOFACIAL INDICATION) 06/02/2009
K992242 PILLAR SURGICAL, INC. PILLAR NASAL, DORSAL COLUMELLA AND NASAL DORSUM IMPLANTS 11/22/1999
K961124 RAND SCIENTIFIC CORP. THE NAUTILUS 04/19/1996
K982753 SEARE BIOMEDICAL CORP. SEARE BIOMEDICAL NASAL IMPLANTS 09/30/1998
K981833 SILIMED, LLC. SILIMED NASAL L SHAPED IMPLANT 06/26/1998
K161548 SOUTHERN IMPLANTS (PTY) LTD. Osseointegrated Fixtures 12/01/2016
K983755 SURGICAL TECHNOLOGY LABORATORIES, INC. NASAL DORSAL SERIES 11/20/1998


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