Product code GZT— Neurology
CRANK FRAME RETRACTOR
- Classification name
- Retractor, Self-Retaining, For Neurosurgery
- Device class
- Class 2
- Regulation
- 21 CFR 882.4800
- Advisory panel
- Neurology
- Total cleared
- 43
- First cleared
- Most recent
Market context for product code GZT
FDA has cleared devices under product code GZT between 1980 and 2022, filed by 37 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2022
- 2021
- 2020
- 2018
- 2017
- 2016
- 2015
- 2012
- 2011
- 2010
- 2009
- 2007
- 2006
- 2005
- 1999
Top applicants under product code GZT
Recent clearances under product code GZT
- K210615 — Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull Clamp Mounted (SCM)
- K202694 — Vycor Medical Viewsite Brain Access System (VBAS) and VBAS with Alignment Clip (VBAS AC) (together the VBAS Family)
- K202072 — MindsEye Expandable Port
- K180610 — Geister retractor for neuro - and spine surgery
- K172433 — NICO BrainPath
- K161680 — MEDICON Spinal Spreading Systems
- K161318 — Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding Systems
- K161004 — Self-retaining Retractor
- K150378 — NICO BrainPath & Accessories, NICO BrainPath, NICO Shepherd's Hook
- K120691 — BRAIN PORT
- K113273 — SPOTLIGHT ACCESS SYSTEM
- K112913 — SPOTLIGHT ACCESS SYSTEM
- K093054 — SCALP DURA RETRACTOR, MODEL KS00474
- K090272 — SPETZLER SCALP RETRACTOR CLAMPS (VARIOUS STYLES AND SIZES)
- K071771 — INSTRUMED RETRACTORS
- K071338 — FLEX ARM RETRACTOR SYSTEM
- K062814 — PIPELINE II ACCESS SYSTEM
- K060973 — VYCOR SURGICAL ACCESS SYSTEMS
- K060097 — GROSSMAN SELF-RETAINING LOW PROFILE BRAIN RETRACTOR, MODEL 04-001-00
- K050706 — HARMONY PORT SYSTEM, MODEL 1907 SERIES
- K992898 — THE BRIGHT MEDICAL DILATION RETRACTOR SYSTEM
- K964402 — VERSATRAC (TM) LUMBAR RETRACTOR SYSTEM
- K960807 — TEW CRANIAL/SPINAL RETRACTOR MODEL A1090
- K945040 — HAMID HOOK ATTACHMENT DEVICE FOR HEMILAMINECTOMY RETRACTOR
- K935529 — CERVICAL SELF-RETAINING RETRACTOR
- K924876 — TENS DEVICE FOR RELIEF OF CHRONIC PAIN, MODIFIED
- K913233 — CODMAN LHALO SPLIT RING RETRACTOR SYSTEM
- K910621 — BLADES FOR SPINAL LAMINECTOMY RETRACTOR
- K905445 — ADSON-BECKMAN RETRACTOR, SPINAL
- K902517 — NEUROSURGICAL HEADFRAME ACCESSORIES
- K885120 — ESI MODEL MS-103
- K896156 — COMPASS(TM) STEREOTACTIC RETRACTOR SYSTEM
- K895395 — V. MUELLER RHOTON SELF-RETAINING BRAIN RETRACTOR
- K895537 — MODIFIED MEMORY RETRACTOR ARM
- K892543 — NEUROSURICAL RETRACTORS - VARIOUS TYPES
- K882071 — CRANK FRAME RETRACTOR
- K881160 — CRANK FRAME RETRACTOR
- K874829 — MEDCO MEMORY RETRACTOR SYSTEM
- K874956 — SELF-RETAINING RETRACTOR FOR NEUROSURGERY
- K873691 — CEDAR(TM) RETRACTOR RING
- K830332 — BUDDE-HALO RETRACTOR
- K801855 — CYCLOPAC TENS
- K801151 — DISPOSABLE SKIN RETRACTOR
Data sourced from openFDA. This site is unofficial and independent of the FDA.