FDA.reportPublic FDA data

Sapphire X3

Primary DI
00840606178211
Brand
Sapphire X3
Company
SPINAL ELEMENTS, INC.
Model
27081-013
Device description
1-LEVEL SAPPHIRE X3, 13MM, 17.5MM WIDE
Published
2024-02-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
KWQAppliance, Fixation, Spinal Intervertebral Body

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840606178211PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840606178211008406061782118406061782110840606178211

GMDN Terms#

Term, Definition table
TermDefinition
Spinal fixation plate, non-bioabsorbableA small, implantable, non-customized sheet of solid material intended to be attached to the spine with screws for spinal immobilization; 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). 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
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
610712213
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840606188135Ventana A14320-0022026-07-16
00840606188142Ventana A14320-0032026-07-16
00840606188159Ventana A14320-0042026-07-16
00840606188166Ventana A14320-0052026-07-16
00840606188173Ventana A14320-0062026-07-16
00840606188180Ventana A14320-0072026-07-16
00840606188197Ventana A14320-0082026-07-16
00840606188203Ventana A14320-0092026-07-16
00840606188210Ventana A14320-0102026-07-16
00840606188227Ventana A14320-0112026-07-16
00840606188234Ventana A14320-0122026-07-16
00840606188241Ventana A14320-0142026-07-16
00840606188258Ventana A14320-0152026-07-16
00840606188265Ventana A14320-0162026-07-16
00840606188272Ventana A14320-0172026-07-16
00840606188289Ventana A14320-0182026-07-16
00840606188296Ventana A14320-0222026-07-16
00840606188302Ventana A14320-0232026-07-16
00840606188319Ventana A14320-0242026-07-16
00840606188326Ventana A14320-0292026-07-16

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Primary DI, Brand, Company table
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00840493424965RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424972RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424989RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424996RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493425009RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13