Product code GZT
- Device name
- Retractor, Self-Retaining, For Neurosurgery
- Medical specialty
- Neurology
- Device class
- 2
- Regulation number
- 882.4800
- Review panel
- NE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K210615 | Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull Clamp Mounted (SCM) | Thompson Surgical Instruments, Inc. | 2022-05-13 |
| K202694 | Vycor Medical Viewsite Brain Access System (“VBAS”) and VBAS with Alignment Clip (“VBAS AC”) (together the “VBAS Family”) | Vycor Medical, Inc. | 2021-01-14 |
| K202072 | MindsEye Expandable Port | Minnetronix Neuro, Inc. | 2020-08-26 |
| K180610 | Geister retractor for neuro - and spine surgery | Geister Medizin Technik GmbH | 2018-08-29 |
| K172433 | NICO BrainPath | Nico Corporation | 2017-09-07 |
| K161680 | MEDICON Spinal Spreading Systems | Medicon EG | 2017-03-24 |
| K161318 | Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding Systems | Tedan Surgical Innovations, LLC | 2017-03-20 |
| K161004 | Self-retaining Retractor | Fetzer Medical GmbH & Co. KG | 2016-09-09 |
| K150378 | NICO BrainPath & Accessories, NICO BrainPath, NICO Shepherd's Hook | Nico Corporation | 2015-06-12 |
| K120691 | BRAIN PORT | Nico Corporation | 2012-06-05 |
| K113273 | SPOTLIGHT ACCESS SYSTEM | Johnson & Johnson | 2012-01-27 |
| K112913 | SPOTLIGHT ACCESS SYSTEM | Johnson & Johnson | 2011-12-16 |
| K093054 | SCALP DURA RETRACTOR, MODEL KS00474 | KARL STORZ Endoscopy-America, Inc. | 2010-11-15 |
| K090272 | SPETZLER SCALP RETRACTOR CLAMPS (VARIOUS STYLES AND SIZES) | Cardinal Health, Inc. | 2009-03-18 |
| K071771 | INSTRUMED RETRACTORS | Instrumed International, Inc. | 2007-08-02 |
| K071338 | FLEX ARM RETRACTOR SYSTEM | Koros USA, Inc. | 2007-05-29 |
| K062814 | PIPELINE II ACCESS SYSTEM | Depuy Spine, Inc. | 2006-12-15 |
| K060973 | VYCOR SURGICAL ACCESS SYSTEMS | Vycor Medical, LLC | 2006-07-26 |
| K060097 | GROSSMAN SELF-RETAINING LOW PROFILE BRAIN RETRACTOR, MODEL 04-001-00 | KLS-Martin L.P. | 2006-02-27 |
| K050706 | HARMONY PORT SYSTEM, MODEL 1907 SERIES | Spinal Concepts, Inc. | 2005-04-15 |
| K992898 | THE BRIGHT MEDICAL DILATION RETRACTOR SYSTEM | Bright Medical Instruments | 1999-10-21 |
| K964402 | VERSATRAC (TM) LUMBAR RETRACTOR SYSTEM | V. Mueller Neuro/Spine | 1997-01-23 |
| K960807 | TEW CRANIAL/SPINAL RETRACTOR MODEL A1090 | Ohio Medical Instrument Co., Inc. | 1996-05-17 |
| K945040 | HAMID HOOK ATTACHMENT DEVICE FOR HEMILAMINECTOMY RETRACTOR | Hamid M. Mehdizadeh, M.D. | 1995-01-13 |
| K935529 | CERVICAL SELF-RETAINING RETRACTOR | T. Korossurgical Instruments Corp. | 1994-03-22 |
| K924876 | TENS DEVICE FOR RELIEF OF CHRONIC PAIN, MODIFIED | Graham-Field, Inc. | 1994-03-01 |
| K913233 | CODMAN LHALO SPLIT RING RETRACTOR SYSTEM | Codman & Shurtleff, Inc. | 1991-07-31 |
| K910621 | BLADES FOR SPINAL LAMINECTOMY RETRACTOR | International Hospital Supply Co. | 1991-04-01 |
| K905445 | ADSON-BECKMAN RETRACTOR, SPINAL | A. Henniss | 1991-01-25 |
| K902517 | NEUROSURGICAL HEADFRAME ACCESSORIES | Sims Surgical, Inc. | 1990-07-03 |
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|---|---|---|---|
| 00816744028459 | NICO BrainPath | NICO CORPORATION | 2020-04-15 |
| 10381780253235 | Integra® | INTEGRA LIFESCIENCES CORPORATION | 2016-07-26 |
| 10381780253853 | Integra® | INTEGRA LIFESCIENCES CORPORATION | 2016-07-26 |
| 10381780253846 | Integra® | INTEGRA LIFESCIENCES CORPORATION | 2016-07-26 |
| 10381780253839 | Integra® | INTEGRA LIFESCIENCES CORPORATION | 2016-07-26 |
| 10381780253747 | MAYFIELD® | INTEGRA LIFESCIENCES CORPORATION | 2016-07-26 |
| 10381780253730 | MAYFIELD® | INTEGRA LIFESCIENCES CORPORATION | 2016-07-26 |
| 10381780253501 | Budde® | INTEGRA LIFESCIENCES CORPORATION | 2016-07-26 |
| 10381780253495 | Budde® | INTEGRA LIFESCIENCES CORPORATION | 2016-07-26 |
| 10381780253488 | Budde® | INTEGRA LIFESCIENCES CORPORATION | 2016-07-26 |
| 10381780253440 | Budde® | INTEGRA LIFESCIENCES CORPORATION | 2016-07-26 |
| 10381780253433 | Budde® | INTEGRA LIFESCIENCES CORPORATION | 2016-07-26 |
| 10381780253280 | Integra® | INTEGRA LIFESCIENCES CORPORATION | 2016-07-26 |
| 10381780253273 | Integra® | INTEGRA LIFESCIENCES CORPORATION | 2016-07-26 |
| 10381780253266 | Integra® | INTEGRA LIFESCIENCES CORPORATION | 2016-07-26 |
| 10381780253242 | Integra® | INTEGRA LIFESCIENCES CORPORATION | 2016-07-26 |
| 10381780253228 | Budde® | INTEGRA LIFESCIENCES CORPORATION | 2016-07-26 |
| 10381780253204 | Budde® | INTEGRA LIFESCIENCES CORPORATION | 2016-07-26 |
| 10381780253198 | Budde® | INTEGRA LIFESCIENCES CORPORATION | 2016-07-26 |
| 10381780253174 | Integra® | INTEGRA LIFESCIENCES CORPORATION | 2016-07-26 |
| 10381780253143 | Integra® | INTEGRA LIFESCIENCES CORPORATION | 2016-07-26 |
| 10381780253129 | Integra® | INTEGRA LIFESCIENCES CORPORATION | 2016-07-26 |
| 10381780253099 | Integra® | INTEGRA LIFESCIENCES CORPORATION | 2016-07-26 |
| 10381780253075 | Integra® | INTEGRA LIFESCIENCES CORPORATION | 2016-07-26 |
| 10381780253051 | Integra® | INTEGRA LIFESCIENCES CORPORATION | 2016-07-26 |
| 10381780253044 | Integra® | INTEGRA LIFESCIENCES CORPORATION | 2016-07-26 |
| 10381780253037 | Integra® | INTEGRA LIFESCIENCES CORPORATION | 2016-07-26 |
| 10381780253006 | Budde® | INTEGRA LIFESCIENCES CORPORATION | 2016-07-26 |
| 10381780252993 | Budde® | INTEGRA LIFESCIENCES CORPORATION | 2016-07-26 |
| 10381780252986 | Budde® | INTEGRA LIFESCIENCES CORPORATION | 2016-07-26 |