FDA 510(k) Applications for Medical Device Product Code "GZT"
(Retractor, Self-Retaining, For Neurosurgery)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K992898 | BRIGHT MEDICAL INSTRUMENTS | THE BRIGHT MEDICAL DILATION RETRACTOR SYSTEM | 10/21/1999 |
| K090272 | CARDINAL HEALTH, INC. | SPETZLER SCALP RETRACTOR CLAMPS (VARIOUS STYLES AND SIZES) | 03/18/2009 |
| K062814 | DEPUY SPINE, INC. | PIPELINE II ACCESS SYSTEM | 12/15/2006 |
| K161004 | FETZER MEDICAL GMBH & CO.KG | Self-retaining Retractor | 09/09/2016 |
| K180610 | Geister Medizintechnik GmbH | Geister retractor for neuro - and spine surgery | 08/29/2018 |
| K071771 | INSTRUMED INTERNATIONAL, INC. | INSTRUMED RETRACTORS | 08/02/2007 |
| K112913 | JOHNSON & JOHNSON | SPOTLIGHT ACCESS SYSTEM | 12/16/2011 |
| K113273 | JOHNSON & JOHNSON | SPOTLIGHT ACCESS SYSTEM | 01/27/2012 |
| K093054 | KARL STORZ ENDOSCOPY-AMERICA, INC. | SCALP DURA RETRACTOR, MODEL KS00474 | 11/15/2010 |
| K060097 | KLS-MARTIN L.P. | GROSSMAN SELF-RETAINING LOW PROFILE BRAIN RETRACTOR, MODEL 04-001-00 | 02/27/2006 |
| K071338 | KOROS USA, INC. | FLEX ARM RETRACTOR SYSTEM | 05/29/2007 |
| K161680 | MEDICON EG | MEDICON Spinal Spreading Systems | 03/24/2017 |
| K202072 | Minnetronix Neuro, INC. | MindsEye Expandable Port | 08/26/2020 |
| K120691 | NICO CORPORATION | BRAIN PORT | 06/05/2012 |
| K172433 | NICO Corporation | NICO BrainPath | 09/07/2017 |
| K150378 | NICO Corporation | NICO BrainPath & Accessories, NICO BrainPath, NICO Shepherd's Hook | 06/12/2015 |
| K960807 | OHIO MEDICAL INSTRUMENT CO., INC. | TEW CRANIAL/SPINAL RETRACTOR MODEL A1090 | 05/17/1996 |
| K050706 | SPINAL CONCEPTS, INC. | HARMONY PORT SYSTEM, MODEL 1907 SERIES | 04/15/2005 |
| K161318 | TEDAN SURGICAL INNOVATIONS LLC | Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding Systems | 03/20/2017 |
| K210615 | Thompson Surgical Instruments Inc. | Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull Clamp Mounted (SCM) | 05/13/2022 |
| K964402 | V. MUELLER NEURO/SPINE | VERSATRAC (TM) LUMBAR RETRACTOR SYSTEM | 01/23/1997 |
| K202694 | Vycor Medical INC. | Vycor Medical Viewsite Brain Access System (ôVBASö) and VBAS with Alignment Clip (ôVBAS ACö) (together the ôVBAS Familyö) | 01/14/2021 |
| K060973 | VYCOR MEDICAL LLC | VYCOR SURGICAL ACCESS SYSTEMS | 07/26/2006 |
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