Home GUDID 00840606168601 SAPPHIRE X
Primary DI 00840606168601
Brand SAPPHIRE X
Company SPINAL ELEMENTS, INC.
Model 27002-042
Device description 2-LEVEL SAPPHIRE X® CERVICAL PLATE, 42MM
Published 2026-08-27
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name KWQ Appliance, Fixation, Spinal Intervertebral Body
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00840606168601 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00840606168601 00840606168601 840606168601 0840606168601
GMDN Terms# Term, Definition table Term Definition Spinal fixation plate, non-bioabsorbable A small, implantable, non-customized sheet of solid material intended to be attached to the spine with screws for spinal immobilization as part of treatment of a spinal instability or deformity; it 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). Disposable instruments intended to facilitate implantation, or fixation implants (i.e., bone screws), may be packaged with the plate.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 610712213 Device count 1 DM exempt true Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label true Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00840606168533 SAPPHIRE X SPINAL ELEMENTS, INC. KWQ 2026-08-27 00840606168557 SAPPHIRE X SPINAL ELEMENTS, INC. KWQ 2026-08-27 00840606168571 SAPPHIRE X SPINAL ELEMENTS, INC. KWQ 2026-08-27 00840606168588 SAPPHIRE X SPINAL ELEMENTS, INC. KWQ 2026-08-27 00840606168595 SAPPHIRE X SPINAL ELEMENTS, INC. KWQ 2026-08-27 00840606168618 SAPPHIRE X SPINAL ELEMENTS, INC. KWQ 2026-08-27 00840606168625 SAPPHIRE X SPINAL ELEMENTS, INC. KWQ 2026-08-27 00840606168632 SAPPHIRE X SPINAL ELEMENTS, INC. KWQ 2026-08-27 00840606168656 SAPPHIRE X SPINAL ELEMENTS, INC. KWQ 2026-08-27 00840606168663 SAPPHIRE X SPINAL ELEMENTS, INC. KWQ 2026-08-27 00840606168687 SAPPHIRE X SPINAL ELEMENTS, INC. KWQ 2026-08-27 00840606168694 SAPPHIRE X SPINAL ELEMENTS, INC. KWQ 2026-08-27 00840606168717 SAPPHIRE X SPINAL ELEMENTS, INC. KWQ 2026-08-27 00840606168748 SAPPHIRE X SPINAL ELEMENTS, INC. KWQ 2026-08-27 00840606168755 SAPPHIRE X SPINAL ELEMENTS, INC. KWQ 2026-08-27 00840606168779 SAPPHIRE X SPINAL ELEMENTS, INC. KWQ 2026-08-27 00840606168786 SAPPHIRE X SPINAL ELEMENTS, INC. KWQ 2026-08-27 00840606168809 SAPPHIRE X SPINAL ELEMENTS, INC. KWQ 2026-08-27 00840606168816 SAPPHIRE X SPINAL ELEMENTS, INC. KWQ 2026-08-27 00840606168830 SAPPHIRE X SPINAL ELEMENTS, INC. KWQ 2026-08-27 00840606168847 SAPPHIRE X SPINAL ELEMENTS, INC. KWQ 2026-08-27 00840606168861 SAPPHIRE X SPINAL ELEMENTS, INC. KWQ 2026-08-27 00840606168878 SAPPHIRE X SPINAL ELEMENTS, INC. KWQ 2026-08-27 00840606168892 SAPPHIRE X SPINAL ELEMENTS, INC. KWQ 2026-08-27 00840606168908 SAPPHIRE X SPINAL ELEMENTS, INC. KWQ 2026-08-27 00840606168922 SAPPHIRE X SPINAL ELEMENTS, INC. KWQ 2026-08-27 00840606168939 SAPPHIRE X SPINAL ELEMENTS, INC. KWQ 2026-08-27 00840606169769 SAPPHIRE X SPINAL ELEMENTS, INC. KWQ 2026-08-27 00840606169776 SAPPHIRE X SPINAL ELEMENTS, INC. KWQ 2026-08-27 00840606169783 SAPPHIRE X SPINAL ELEMENTS, INC. KWQ 2026-08-27