FDA.reportPublic FDA data

ORIO-3D Cage System

Primary DI
00193082162817
Brand
ORIO-3D Cage System
Company
SPINECRAFT, LLC
Model
820A-60-10
Catalog number
820A-60-10
Device description
ORIO-3D ALIF Cage Screw Remover
Published
2026-05-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHOrthopedic manual surgical instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00193082162817PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00193082162817001930821628171930821628170193082162817

GMDN Terms#

Term, Definition table
TermDefinition
General internal orthopaedic fixation system implantation kitA collection of instruments and devices intended to be used for the placement of an internal orthopaedic fixation system into or onto all types of bones (e.g., bones of limbs, spine, pelvis, or craniomaxillofacial). It is a non-dedicated device that includes various metallic and/or plastic reusable devices [e.g., retractors, rods, clamps, drills, pins, saws, screwdrivers, guides, trials, impactors] intended to be used for the implantation of any type of internal orthopaedic fixation system; the implant(s) is not included. This is a reusable 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
Premarket exempt
true
Serial number
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
00824846013082Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-10-19
00850078396440SYNQ Single-Use Instrument System(1066)Eca Medical InstrumentsLXH2026-10-19
00889024715295Persona Extended V/V Guide Assembly (MFS)Zimmer, Inc.LXH2026-10-19
08809986489807LnK Spinal Instrument SystemL&K BIOMED CO. ,LTD.LXH2026-10-19
00810111228671Cut GuideTreace Medical Concepts, Inc.LXH2026-10-16
00810161900305EARP, TRIAL 22X35X12 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161900312EARP, TRIAL 22X35X14 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161900329EARP, TRIAL 22X35X12 12°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161900336EARP, TRIAL 22X35X14 12°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161901418EARP TRIAL 22x40x10 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161901425EARP TRIAL 22x40x12 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161901432EARP TRIAL 22x40x14 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161901449EARP TRIAL 22x40x12 12°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161901456EARP TRIAL 22x40x14 12°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161901463EARP TRIAL 22x45x10 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161901470EARP TRIAL 22x45x12 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161901487EARP TRIAL 22x45x14 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161901494EARP TRIAL 22x45x12 12°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161901500EARP TRIAL 22x45x14 12°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161901692EARP TRIAL 22x50x10 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161901708EARP TRIAL 22x50x12 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161901715EARP TRIAL 22x50x14 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161901722EARP TRIAL 22x50x12 12°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161901739EARP TRIAL 22x50x14 12°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00840606197007MERCURYSPINAL ELEMENTS, INC.LXH2026-10-16
00840606197014MERCURYSPINAL ELEMENTS, INC.LXH2026-10-16
00840606197021MERCURYSPINAL ELEMENTS, INC.LXH2026-10-16
00840606197038MERCURYSPINAL ELEMENTS, INC.LXH2026-10-16
05055662922622Volition™ Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDLXH2026-10-16
00810161900015EARP DISC SPACER INSERTERRETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15