FDA.reportPublic FDA data

ORIO

Primary DI
00193082003707
Brand
ORIO
Company
SPINECRAFT, LLC
Model
A7206-20
Catalog number
A7206-20
Device description
ORIO-AL PEEK Anterior Lumbar ALIF Cage, 6 deg. Lordosis, 27 X 35 X 20mm
Published
2019-02-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MAXIntervertebral fusion device with bone graft, lumbar
ODPIntervertebral fusion device with bone graft, cervical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2
ODPIntervertebral Fusion Device With Bone Graft, CervicalOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K090887000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K090887000ORIO-C CERVICAL, ORIO-TL TLIF, ORIO-PL PLIF, ORIO-AL ALIF INTERVEDRTEBRAL BODY FUSION CAGESSpineCraft2009-10-30ODP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00193082003707PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00193082003707001930820037071930820037070193082003707

GMDN Terms#

Term, Definition table
TermDefinition
Polymeric spinal interbody fusion cageA device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of non-bioabsorbable synthetic polymer [e.g., polyetheretherketone (PEEK)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be included with the device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(630)920-7300info@spinecraft.com

Regulatory Flags#

DUNS number
783908713
Device count
1
DM exempt
true
Lot or batch
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00193082164828ORIO-3D Cage System820A-210820A-2102026-07-30
00193082167416ORIO-3D Cage System820C-210-2820C-210-22026-07-30
00193082167430ORIO-3D Cage System820A-200820A-2002026-07-30
00193082167447ORIO-3D Cage System820A-100820A-1002026-07-30
00193082167454ORIO-3D Cage System820A-210-1820A-210-12026-07-30
00193082167461ORIO-3D Cage System820A-210-2820A-210-22026-07-30
00193082167478ORIO-3D Cage System820A-210-3820A-210-32026-07-30
00193082167492ANTERIS Thoracolumbar Plate System820A-310820A-3102026-07-30
00193082167508ANTERIS Thoracolumbar Plate System820A-310-1820A-310-12026-07-30
00193082162084ANTERIS Thoracolumbar Plate SystemLPS-APSD-10LPS-APSD-102026-05-20
00193082162091ANTERIS Thoracolumbar Plate SystemLPS-APSD-12LPS-APSD-122026-05-20
00193082162107ANTERIS Thoracolumbar Plate SystemLPS-APSD-14LPS-APSD-142026-05-20
00193082162114ANTERIS Thoracolumbar Plate SystemLPS-APSD-16LPS-APSD-162026-05-20
00193082162121ANTERIS Thoracolumbar Plate SystemLPS-APSD-18LPS-APSD-182026-05-20
00193082162138ANTERIS Thoracolumbar Plate SystemLPS-APSD-20LPS-APSD-202026-05-20
00193082162145ANTERIS Thoracolumbar Plate SystemLPS-APSD-22LPS-APSD-222026-05-20
00193082162152ANTERIS Thoracolumbar Plate SystemLPS-APSD-24LPS-APSD-242026-05-20
00193082162169ANTERIS Thoracolumbar Plate SystemLPS-APSL-10LPS-APSL-102026-05-20
00193082162176ANTERIS Thoracolumbar Plate SystemLPS-APSL-12LPS-APSL-122026-05-20
00193082162183ANTERIS Thoracolumbar Plate SystemLPS-APSL-14LPS-APSL-142026-05-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00843511102852Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-18
00843511102852Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-18
00843511102869Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-18
00843511102869Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-18
00843511102876Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-18
00843511102876Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-18
00843511102883Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-18
00843511102883Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-18
00843511102890Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-18
00843511102890Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-18
00843511102906Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-18
00843511102906Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-18
00843511102913Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-18
00843511102913Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-18
00843511102920Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-18
00843511102920Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-18
00193982141097HEDRONGLOBUS MEDICAL, INC.MAX2026-08-14
00193982141103HEDRONGLOBUS MEDICAL, INC.MAX2026-08-14
00193982141110HEDRONGLOBUS MEDICAL, INC.MAX2026-08-14
00193982141127HEDRONGLOBUS MEDICAL, INC.MAX2026-08-14
00193982141134HEDRONGLOBUS MEDICAL, INC.MAX2026-08-14
00193982141141HEDRONGLOBUS MEDICAL, INC.MAX2026-08-14
00193982141158HEDRONGLOBUS MEDICAL, INC.MAX2026-08-14
00193982141165HEDRONGLOBUS MEDICAL, INC.MAX2026-08-14
00193982141172HEDRONGLOBUS MEDICAL, INC.MAX2026-08-14
00193982141189HEDRONGLOBUS MEDICAL, INC.MAX2026-08-14
00193982141196HEDRONGLOBUS MEDICAL, INC.MAX2026-08-14
00193982141202HEDRONGLOBUS MEDICAL, INC.MAX2026-08-14
00193982141240HEDRONGLOBUS MEDICAL, INC.MAX2026-08-14
00193982141257HEDRONGLOBUS MEDICAL, INC.MAX2026-08-14