FDA 510(k) Applications for Medical Device Product Code "HAE"
(Rongeur, Manual)

FDA 510(k) Number Applicant Device Name Decision Date
K080494 BAXANO, INC. BAXANO ULTRA LOW PROFILE RONGEUR 03/04/2008
K113073 BAXANO, INC. IO-TOME DEVICE 07/27/2012
K063231 BAXANO, INC. MICROBLADE SHAVER AND ACCESSORIES 04/16/2007
K100958 BAXANO, INC. MODIFICATION TO: MICROBLADE SHAVER AND ACCESSORIES 07/23/2010
K113533 BAXANO, INC. NEURO CHECK DEVICE WITH IO-FLEX WIRE 04/11/2012
K062711 BAXANO, INC. ULTRA LOW PROFILE RONGEUR 03/07/2007
K023868 DANNORITZER MEDICAL INSTRUMENTS DAN KERRISON RONGEURS, MODELS K1 + BILLY 1 02/07/2003
K943583 ENTERPRISE MEDICAL CORP. KERRISON RONGEURS 02/21/1995
K153243 Fehling Instruments GmbH & Co. KG Fehling-Punches 08/04/2016
K081651 INSTRUMED INTERNATIONAL, INC. INSTRUMED RONGEUR 08/08/2008
K150428 INTEGRA LIFESCIENCES CORP. Integra (R) Jarit (R) Kerrison Rongeurs, Integra (R) Ruggles (TM)-Redmons (TM) Kerrison Rongeurs, Integra (R) Miltex (R) Kerrison Rongeurs, Integra (R) Meisterhand (R) Kerrison Rongeurs 04/16/2015
K092227 INTEGRA LIFESCIENCES CORP. JARIT, RUGGLES, R&B REDMOND/ REDMOND, MILTEX, MEISTERHAND - KERRISON RONGEURS 02/17/2010
K954699 JOHNSON & JOHNSON PROFESSIONALS, INC. BRAY RONGEUR 12/06/1995
K150468 K2 Medical GmbH & Co. KG Laminectomy Rongeurs, Kerrison Rongeurs, IVD Rongeurs 02/29/2016
K131851 OSTEOMED OSTEOMED NEURO RONGEUR 12/06/2013
K933978 REDMOND NEUROTECHNOLOGIES CORP. NEDBOND EJECTOR KERRISON RONGEUR 01/12/1994
K875043 SOLWAY, INC. RONGEUR (NEUROSURGICAL INSTRUMENTS) 01/22/1988
K903401 SUR-MED INSTRUMENTS, INC. SPECIAL RONGEUR 08/10/1990
K130541 SYMMETRY SURGICAL SYMMETRY KERRISON DISPOSABLE TIP RONGEURS 08/05/2013
K161744 Symmetry Surgical Inc. Symmetry Sharp Kerrison Rongeur 09/07/2016
K943116 UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC AUTO SUTURE KERRISON SPINAL RONGEUR 07/27/1994
K943635 V. MUELLER NEURO/SPINE ULTRA-LINE RONGEUR 12/07/1994
K152734 VITALITEC MEDIZINTECHNIK GMBH Kerrison Rongeurs 06/18/2016
K901313 VON ZEPPELIN GMBH INSTRUMENTS FOR NEUROLOGICAL SURGERY 07/23/1990
K903151 VON ZEPPELIN GMBH INTERVERTEBRAL DISC RONGEUR 12/11/1990
K901372 ZEPPELIN GMBH LAMINECTOMY RONGEUR 06/28/1990
K892535 ZINNANTI SURGICAL INSTRUMENTS, INC. NEUROLOGICAL RONGEURS - VARIOUS TYPES 05/11/1989


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