FDA.reportPublic FDA data

Sapphire X3

Primary DI
00840606176521
Brand
Sapphire X3
Company
SPINAL ELEMENTS, INC.
Model
27071-013
Device description
1-LEVEL SAPPHIRE X3, 13MM, 16.5MM 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
00840606176521PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840606176521008406061765218406061765210840606176521

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
00840606185110LUNA TiLUN20006-10T2026-09-25
00840606185127LUNA TiLUN20006-12T2026-09-25
00840606185134LUNA TiLUN20006-14T2026-09-25
00840606185141LUNA TiLUN20012-12T2026-09-25
00840606185158LUNA TiLUN20012-14T2026-09-25
00840606185165LUNA TiLUN20012-16T2026-09-25
00840606186223ALIF Disc Prep11044-0002026-09-25
00840606186230ALIF Disc Prep15161-0002026-09-25
00840606186261ALIF15163-0022026-09-25
00840606186278ALIF15163-0032026-09-25
00840606186285ALIF15163-0042026-09-25
00840606187381ALIF15301-0002026-09-25
00840606187565Ventana A40050-0202026-09-25
00840606187572Ventana A40050-0252026-09-25
00840606187589Ventana A40050-0302026-09-25
00840606187596Ventana A40050-0352026-09-25
00840606187602Ventana A40060-0202026-09-25
00840606187619Ventana A40060-0252026-09-25
00840606187633Ventana A40060-0352026-09-25
00840606196024Vertu53067-0012026-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810017915125SABER-XA, Screw Ø5.0 x 22.5ELEVATION SPINE, INC.KWQ2026-09-22
00810017915149SABER-XA, Screw Ø5.0 x 32.5ELEVATION SPINE, INC.KWQ2026-09-22
00810017915156SABER-XA, Screw Ø5.5 x 22.5ELEVATION SPINE, INC.KWQ2026-09-22
00810017915163SABER-XA, Screw Ø5.5 x 27.5ELEVATION SPINE, INC.KWQ2026-09-22
00810017915170SABER-XA, Screw Ø5.5 x 32.5ELEVATION SPINE, INC.KWQ2026-09-22
10888857598164Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598171Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598188Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598195Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598201Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598218Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598225Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598232Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598249Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
00810056993146corraCarlsmed, Inc.KWQ2026-01-30
00613994568311TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2015-08-05
00613994568823TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2015-08-05
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04546540147769XIA IIStryker CorporationKWQ2014-12-08
04546540147806XIA IIStryker CorporationKWQ2014-12-08
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04546540147912XIA IStryker CorporationKWQ2014-12-08
04546540147929XIA IStryker CorporationKWQ2014-12-08
04546540147936XIA IStryker CorporationKWQ2014-12-08
04546540147974XIA IStryker CorporationKWQ2014-12-08
04546540147981XIA IStryker CorporationKWQ2014-12-08
04546540147998XIA IStryker CorporationKWQ2014-12-08
04546540148001XIA IIStryker CorporationKWQ2014-12-08
04546540148018XIA IIStryker CorporationKWQ2014-12-08
04546540148025XIA IIStryker CorporationKWQ2014-12-08