FDA.reportPublic FDA data

A8 INTEGR8® Porous Pedicle Screw System

Primary DI
00850080774342
Brand
A8 INTEGR8® Porous Pedicle Screw System
Company
ALLUMIN8, INC.
Model
A8NS-002-0032
Catalog number
A8NS-002-0032
Device description
T25 Hexalobe Final Driver
Published
2026-02-27
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
00850080774342PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850080774342008500807743428500807743420850080774342

GMDN Terms#

Term, Definition table
TermDefinition
Surgical screwdriver, reusableA non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1 (417) 689-2424info@allumin8.com

Regulatory Flags#

DUNS number
121774080
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20850062071012A8 INTEGR8® Porous Pedicle Screw SystemA8-55-0030-1A8-55-0030-12026-05-15
20850062071029A8 INTEGR8® Porous Pedicle Screw SystemA8-55-0035-1A8-55-0035-12026-05-15
20850062071036A8 INTEGR8® Porous Pedicle Screw SystemA8-55-0040-1A8-55-0040-12026-05-15
20850062071043A8 INTEGR8® Porous Pedicle Screw SystemA8-55-0045-1A8-55-0045-12026-05-15
20850062071050A8 INTEGR8® Porous Pedicle Screw SystemA8-55-0050-1A8-55-0050-12026-05-15
20850062071067A8 INTEGR8® Porous Pedicle Screw SystemA8-55-0055-1A8-55-0055-12026-05-15
20850062071074A8 INTEGR8® Porous Pedicle Screw SystemA8-55-0060-1A8-55-0060-12026-05-15
20850062071081A8 INTEGR8® Porous Pedicle Screw SystemA8-60-0030-1A8-60-0030-12026-05-15
20850062071098A8 INTEGR8® Porous Pedicle Screw SystemA8-60-0035-1A8-60-0035-12026-05-15
20850062071104A8 INTEGR8® Porous Pedicle Screw SystemA8-60-0040-1A8-60-0040-12026-05-15
20850062071111A8 INTEGR8® Porous Pedicle Screw SystemA8-60-0045-1A8-60-0045-12026-05-15
20850062071128A8 INTEGR8® Porous Pedicle Screw SystemA8-60-0050-1A8-60-0050-12026-05-15
20850062071135A8 INTEGR8® Porous Pedicle Screw SystemA8-60-0055-1A8-60-0055-12026-05-15
20850062071142A8 INTEGR8® Porous Pedicle Screw SystemA8-60-0060-1A8-60-0060-12026-05-15
20850062071159A8 INTEGR8® Porous Pedicle Screw SystemA8-65-0030-1A8-65-0030-12026-05-15
20850062071166A8 INTEGR8® Porous Pedicle Screw SystemA8-65-0035-1A8-65-0035-12026-05-15
20850062071173A8 INTEGR8® Porous Pedicle Screw SystemA8-65-0040-1A8-65-0040-12026-05-15
20850062071180A8 INTEGR8® Porous Pedicle Screw SystemA8-65-0045-1A8-65-0045-12026-05-15
20850062071197A8 INTEGR8® Porous Pedicle Screw SystemA8-65-0050-1A8-65-0050-12026-05-15
20850062071203A8 INTEGR8® Porous Pedicle Screw SystemA8-65-0055-1A8-65-0055-12026-05-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00818720013398SuperCable® ISO-Elastic™ Cerclage SystemKinamed, Inc.LXH2026-07-22
00818720013404SuperCable® ISO-Elastic™ Cerclage SystemKinamed, Inc.LXH2026-07-22
00818720013411SuperCable® ISO-Elastic™ Cerclage SystemKinamed, Inc.LXH2026-07-22
00818720013428SuperCable® ISO-Elastic™ Cerclage SystemKinamed, Inc.LXH2026-07-22
00818720013435KineMatch® PFR SystemKinamed, Inc.LXH2026-07-22
00818720013442KineMatch® PFR SystemKinamed, Inc.LXH2026-07-22
00850075111121NativeINS ORTHO INC.LXH2026-07-22
10810128463116StayPort™ shoulder reusable obturator 5 mm x 70 mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-07-21
10810128463123StayPort™ shoulder reusable obturator 5 mm x 90 mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-07-21
10810128463130StayPort™ shoulder reusable obturator 7 mm x 70 mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-07-21
10810128463154StayPort™ shoulder reusable obturator 9 mm x 70 mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-07-21
10810128463161StayPort™ shoulder reusable obturator 9 mm x 90 mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-07-21
10810128463178StayPort™ hip reusable adjustable obturator 9 mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-07-21
00840097536699Kinos Aeros InstrumentationRestor3d, Inc.LXH2026-07-20
08809945895304EXULTCorentec Co., LtdLXH2026-07-20
B504SRAR1930S0ArthrexProvisionLXH2026-07-20
00763000675028n/aMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-19
00824846002468Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-19
00763000837198Medtronic Reusable Instruments & AccessoriesMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-18
00199150041183N/AMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-17
00199150076024Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-17
00763000891329Medtronic Reusable Instruments & AccessoriesMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-17
00840314263636gSourceGSOURCE LLCLXH2026-07-17
00840314264190gSourceGSOURCE LLCLXH2026-07-17
00840314264268gSourceGSOURCE LLCLXH2026-07-17
00840314264404gSourceGSOURCE LLCLXH2026-07-17
00840314264473gSourceGSOURCE LLCLXH2026-07-17
00840314264541gSourceGSOURCE LLCLXH2026-07-17
00840314264619gSourceGSOURCE LLCLXH2026-07-17
00840314264688gSourceGSOURCE LLCLXH2026-07-17