FDA.reportPublic FDA data

Qfix® Carbon Fiber Pelvis System

Primary DI
10841962108628
Brand
Qfix® Carbon Fiber Pelvis System
Company
Qfix
Model
RT-4526S
Catalog number
RT-4526S
Device description
Qfix Carbon Fiber Pelvis System Includes Knee Wedge and set of 6” Opti-Handles
Published
2016-09-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IYEAccelerator, linear, medical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYEAccelerator, Linear, MedicalRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10841962108628PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1084196210862810841962108628

GMDN Terms#

Term, Definition table
TermDefinition
Radiological pelvis positionerA device intended to facilitate adequate positioning and immobilization of the patient's pelvic area during diagnostic imaging procedures, image-guided surgical or interventional procedures, and/or radiation therapy procedures. The device is in the form of a frame, board, cushion, or preformed pad that may also be used to facilitate reproducible positioning for serial imaging studies or serial radiation therapy treatments.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(610)268-0585Compliance@qfix.com

Regulatory Flags#

DUNS number
808875397
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841962120562FibreplastRT-A182KYSDNRT-A182KYSDN2026-05-26
00841962120425Opti Handle Thermoplastic AdapterRT-4546-05RT-4546-052026-05-18
00841962120319Aquaplast PS™PS-1309CSSPS-1309CSS2025-07-09
10841962107447Aquaplast PS™PS-1307PS-13072016-09-13
10841962108307VacQfix™RT-4517-4079VF15RT-4517-4079VF152016-09-13
10841962109090QUANTUM™ CT OverlayRT-4550TE24RT-4550TE242016-09-13
10841962109274kVue™ EdgeRT-4551KVERT-4551KVE2016-09-13
10841962109403Stradivarius™RT-4558CB01RT-4558CB012016-09-13
10841962109441kVue™ Stradivarius™RT-4558KV1RT-4558KV12016-09-13
10841962108000SofTouch™RT-4464-1RT-4464-12016-09-13
10841962108130VacQfix™RT-4517100130PENF45MRT-4517100130PENF45M2016-09-13
10841962108147VacQfix™RT-4517-100150F70RT-4517-100150F702016-09-13
10841962108161VacQfix™RT-4517-100220F120RT-4517-100220F1202016-09-13
10841962108055VacQfix™RT-4517-0003RT-4517-00032016-09-13
10841962119181VacQfix™RT-4517-70230F65FMRT-4517-70230F65FM2022-02-03
00841962120463Dexalign™ Hand Positioner RT-5401RT-54012026-04-28
00841962120470JointGlow™ Hand PositionerRT-5402RT-54022026-04-28
00841962120548Alpine Stirrups, Metric, LeftRT-5100-54L-CERT-5100-54L-CE2026-04-14
00841962120555Alpine Stirrups, Metric, RightRT-5100-54R-CERT-5100-54R-CE2026-04-14
10841962111093Thermoplastic Nasal SplintsTHERMTHERM2021-01-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08057014731224LIAC HWLS.I.T. SORDINA IORT TECHNOLOGIES SPAIYE2026-04-30
08057014731231LIAC HWLS.I.T. SORDINA IORT TECHNOLOGIES SPAIYE2026-04-30
08720168162595Mask DSPS®-PROSH set/5MACROMEDICS B.V.IYE2026-04-23
08720168162564DSPS-Prominent® Cradle-IIMACROMEDICS B.V.IYE2026-04-22
08720168162571Mask DSPS®-PROSHVRL set/5MACROMEDICS B.V.IYE2026-04-22
08720168162618Mask DSPS®-PROSHL set/5MACROMEDICS B.V.IYE2026-04-22
08720168162649Mask DSPS®-PROSHVR set/5MACROMEDICS B.V.IYE2026-04-22
08720168162748Mask DSPS®-PROH, set/5MACROMEDICS B.V.IYE2026-04-22
08720168162755Mask DSPS®-PRO, set/5MACROMEDICS B.V.IYE2026-04-22
08720168162779DSPS-Prominent® Cradle-IIIMACROMEDICS B.V.IYE2026-04-22
08720168162786DSPS-Prominent® Cradle-IVMACROMEDICS B.V.IYE2026-04-22
08720168162793DSPS-Prominent® Cradle-VIMACROMEDICS B.V.IYE2026-04-22
08720168162854Mask DSPS®-PROSCVRL set/5MACROMEDICS B.V.IYE2026-04-22
08720168162861Mask DSPS®-PROSC set/5MACROMEDICS B.V.IYE2026-04-22
08720168162878Mask DSPS®-PROSCVR set/5MACROMEDICS B.V.IYE2026-04-22
08720168162885Mask DSPS®-PROSCL set/5MACROMEDICS B.V.IYE2026-04-22
08720168163325DSPS-Prominent® Cradle-VIIMACROMEDICS B.V.IYE2026-04-22
08720168163356DSPS-Prominent® SH profile set/2MACROMEDICS B.V.IYE2026-04-22
08720168163387DSPS PRO Mask Shim Set HNSMACROMEDICS B.V.IYE2026-04-22
08720168163394DSPS PRO Mask Shim Set HOMACROMEDICS B.V.IYE2026-04-22
08720168160140DSPS-Prominent® baseplate MACROMEDICS B.V.IYE2026-04-21
08720168162557DSPS-Prominent® Cradle-IMACROMEDICS B.V.IYE2026-04-21
08720168162908Handgrips HNS, set/2MACROMEDICS B.V.IYE2026-04-21
EPTWS070031Q5200VERIQAPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHIYE2026-04-17
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EPTWTM600230microSiliconPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHIYE2026-04-15
EPTWTN600220microSilicon XPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHIYE2026-04-15
EPTWTN600230microSiliconPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHIYE2026-04-15
EPTWTW600220microSilicon XPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHIYE2026-04-15