Home GUDID B064XM21617081 Cervical Interbody 17mm x 13.5mm x 8mm
Primary DI B064XM21617081
Brand Cervical Interbody 17mm x 13.5mm x 8mm
Company XENCO MEDICAL LLC
Model XM-216-1708
Published 2018-02-06
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B064XM21617081 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Spinal fixation plate, non-bioabsorbable A small implantable sheet of solid material that is attached to the spine with screws for spinal immobilization and is made of a material that is not chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is typically used to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities (e.g., during anterior/posterior cervical, anterior/posterior lumbar, thoracolumbar, and occipital fixation procedures).
Sterilization Methods# Method table Method Radiation Sterilization
Regulatory Flags# DUNS number 079282130 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit true Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published B064XM3D31223121 CancelleX™ 13mm x 12mm x 12mm x 12* Cervical Interbody XM-3D-312-2312 2026-02-06 B064XM3D31225061 CancelleX™ 15mm x 13mm x 6mm x 12* Cervical Interbody XM-3D-312-2506 2026-02-06 B064XM3D31225071 CancelleX™ 15mm x 13mm x 7mm x 12* Cervical Interbody XM-3D-312-2507 2026-02-06 B064XM3D31225081 CancelleX™ 15mm x 13mm x 8mm x 12* Cervical Interbody XM-3D-312-2508 2026-02-06 B064XMPHCP610081 8mm One Level Cervical Plate XM-PH-CP6-1008 2026-02-06 B064HB11200101 Tube Guard HB-112-0010 2023-08-07 B064MPE010101 Saratoga Cervical Brace MPE01010 2023-08-07 B064MPE010401 Tahiti Lumbar Brace MPE01040 2023-08-07 B064XM11510001 Pedicle Screw Instruments Kit XM-115-1000 2022-08-11 B064XM12323451 23mm x 10mm PLIF Trial Kit 12, 13, 14, 15 mm Heights XM-123-2345 2015-10-28 B064XM12723451 27mm x 12mm TLIF Trial Kit 12, 13, 14, 15 mm Heights XM-127-2345 2015-10-28 B064XM12789011 27mm x 12mm TLIF Trial Kit 8, 9, 10, 11 mm Heights XM-127-8901 2015-10-28 B064XM12823451 28mm x 11mm Oblique Trials 12, 13, 14, 15 mm Heights XM-128-2345 2016-07-06 B064XM12889011 28mm x 11mm Oblique Trial Kit 8, 9, 10, 11 mm Heights XM-128-8901 2015-10-28 B064XM21565501 Ø6.5mm x 50mm Pedicle Screw with Set Screw Package XM-215-6550 2015-10-27 B064XM21565551 Ø6.5mm x 55mm Pedicle Screw with Set Screw Package XM-215-6555 2015-10-27 B064XM21575251 Ø7.5mm x 25mm Pedicle Screw with Set Screw Package XM-215-7525 2015-10-27 B064XM21575271 Ø7.5mm x 27mm Pedicle Screw with Set Screw Package XM-215-7527 2015-11-03 B064XM21575301 Ø7.5mm x 30mm Pedicle Screw with Set Screw Package XM-215-7530 2015-11-03 B064XM21575321 Ø7.5mm x 32mm Pedicle Screw with Set Screw Package XM-215-7532 2015-11-03
Other Devices Sharing Product Codes# 
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