Retractor, Self-Retaining, For Neurosurgery

FDA product code GZT · 43 cleared devices

Class 2 Neurology

Regulation: 21 CFR 882.4800
Review panel: NE
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1980-05-20 – 2026-09-17

GZT 2026-09-17

Durashield Device Kit

Applicant SurGenTec, LLC

K number K252995

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GZT 2022-05-13

Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull Clamp Mounted (SCM)

Applicant Thompson Surgical Instruments, Inc.

K number K210615

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GZT 2021-01-14

Vycor Medical Viewsite Brain Access System (“VBAS”) and VBAS with Alignment Clip (“VBAS AC”) (together the “VBAS Family”)

Applicant Vycor Medical, Inc.

K number K202694

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GZT 2020-08-26

MindsEye Expandable Port

Applicant Minnetronix Neuro, Inc.

K number K202072

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GZT 2018-08-29

Geister retractor for neuro - and spine surgery

Applicant Geister Medizin Technik GmbH

K number K180610

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GZT 2017-09-07

NICO BrainPath

Applicant Nico Corporation

K number K172433

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GZT 2017-03-24

MEDICON Spinal Spreading Systems

Applicant Medicon EG

K number K161680

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GZT 2017-03-20

Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding Systems

Applicant Tedan Surgical Innovations, LLC

K number K161318

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GZT 2016-09-09

Self-retaining Retractor

Applicant Fetzer Medical GmbH & Co. KG

K number K161004

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GZT 2012-06-05

BRAIN PORT

Applicant Nico Corporation

K number K120691

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GZT 2012-01-27

SPOTLIGHT ACCESS SYSTEM

Applicant Johnson & Johnson

K number K113273

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GZT 2011-12-16

SPOTLIGHT ACCESS SYSTEM

Applicant Johnson & Johnson

K number K112913

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GZT 2010-11-15

SCALP DURA RETRACTOR, MODEL KS00474

Applicant KARL STORZ Endoscopy-America, Inc.

K number K093054

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GZT 2009-03-18

SPETZLER SCALP RETRACTOR CLAMPS (VARIOUS STYLES AND SIZES)

Applicant Cardinal Health, Inc.

K number K090272

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GZT 2007-08-02

INSTRUMED RETRACTORS

Applicant Instrumed International, Inc.

K number K071771

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GZT 2007-05-29

FLEX ARM RETRACTOR SYSTEM

Applicant Koros USA, Inc.

K number K071338

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GZT 2006-12-15

PIPELINE II ACCESS SYSTEM

Applicant Depuy Spine, Inc.

K number K062814

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GZT 2006-07-26

VYCOR SURGICAL ACCESS SYSTEMS

Applicant Vycor Medical, LLC

K number K060973

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GZT 2006-02-27

GROSSMAN SELF-RETAINING LOW PROFILE BRAIN RETRACTOR, MODEL 04-001-00

Applicant KLS-Martin L.P.

K number K060097

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GZT 2005-04-15

HARMONY PORT SYSTEM, MODEL 1907 SERIES

Applicant Spinal Concepts, Inc.

K number K050706

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GZT 1999-10-21

THE BRIGHT MEDICAL DILATION RETRACTOR SYSTEM

Applicant Bright Medical Instruments

K number K992898

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GZT 1997-01-23

VERSATRAC (TM) LUMBAR RETRACTOR SYSTEM

Applicant V. Mueller Neuro/Spine

K number K964402

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GZT 1996-05-17

TEW CRANIAL/SPINAL RETRACTOR MODEL A1090

Applicant Ohio Medical Instrument Co., Inc.

K number K960807

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GZT 1995-01-13

HAMID HOOK ATTACHMENT DEVICE FOR HEMILAMINECTOMY RETRACTOR

Applicant Hamid M. Mehdizadeh, M.D.

K number K945040

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GZT 1994-03-22

CERVICAL SELF-RETAINING RETRACTOR

Applicant T. Korossurgical Instruments Corp.

K number K935529

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GZT 1994-03-01

TENS DEVICE FOR RELIEF OF CHRONIC PAIN, MODIFIED

Applicant Graham-Field, Inc.

K number K924876

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GZT 1991-07-31

CODMAN LHALO SPLIT RING RETRACTOR SYSTEM

Applicant Codman & Shurtleff, Inc.

K number K913233

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GZT 1991-04-01

BLADES FOR SPINAL LAMINECTOMY RETRACTOR

Applicant International Hospital Supply Co.

K number K910621

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GZT 1991-01-25

ADSON-BECKMAN RETRACTOR, SPINAL

Applicant A. Henniss

K number K905445

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GZT 1990-07-03

NEUROSURGICAL HEADFRAME ACCESSORIES

Applicant Sims Surgical, Inc.

K number K902517

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GZT 1990-01-19

ESI MODEL MS-103

Applicant Electrical Systems Div.

K number K885120

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GZT 1989-12-06

COMPASS(TM) STEREOTACTIC RETRACTOR SYSTEM

Applicant Stereotactic Medical Systems, Inc.

K number K896156

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GZT 1989-10-19

V. MUELLER RHOTON SELF-RETAINING BRAIN RETRACTOR

Applicant Baxter Healthcare Corp

K number K895395

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GZT 1989-09-22

MODIFIED MEMORY RETRACTOR ARM

Applicant Medical Equipment Development Co., Inc.

K number K895537

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GZT 1989-05-05

NEUROSURICAL RETRACTORS - VARIOUS TYPES

Applicant Zinnanti Surgical Instruments, Inc.

K number K892543

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GZT 1988-06-10

CRANK FRAME RETRACTOR

Applicant Karlin Technology, Inc.

K number K882071

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GZT 1988-04-06

CRANK FRAME RETRACTOR

Applicant T. Korossurgical Instruments Corp.

K number K881160

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GZT 1988-03-24

MEDCO MEMORY RETRACTOR SYSTEM

Applicant Medical Equipment Development Co., Inc.

K number K874829

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GZT 1988-01-28

SELF-RETAINING RETRACTOR FOR NEUROSURGERY

Applicant Solway, Inc.

K number K874956

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GZT 1987-09-28

CEDAR(TM) RETRACTOR RING

Applicant Cedar Surgical, Inc.

K number K873691

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GZT 1983-03-02

BUDDE-HALO RETRACTOR

Applicant Ohio Medical Instrument Co., Inc.

K number K830332

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GZT 1980-08-13

CYCLOPAC TENS

Applicant Dow Corning Wright

K number K801855

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GZT 1980-05-20

DISPOSABLE SKIN RETRACTOR

Applicant Cimarron Instruments, Inc.

K number K801151

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