FDA.reportPublic FDA data

A8 INTEGR8® Porous Pedicle Screw System

Primary DI
20850062071029
Brand
A8 INTEGR8® Porous Pedicle Screw System
Company
ALLUMIN8, INC.
Model
A8-55-0035-1
Catalog number
A8-55-0035-1
Device description
A8 INTEGR8 Cannulated Fenestrated Porous Pedicle Screw - 1PK, Ø5.5x35mm
Published
2026-05-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NKBThoracolumbosacral Pedicle Screw System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K242827000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242827000A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.2025-10-20NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20850062071029PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2085006207102920850062071029

GMDN Terms#

Term, Definition table
TermDefinition
Spinal bone screw, non-bioabsorbableA small, threaded, implantable rod with a screw head and drive intended for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (e.g., surgical steel, titanium alloy, carbon fibre). It is available in various types (e.g., pedicle or transfacet, with a slotted, cross, star, or polygonal drive), and is typically used to provide immobilization and stabilization of spinal segments in the treatment of spinal instabilities or deformities. A screw head adaptor intended to stabilize a rod may be included with the screw.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length35Millimeter
Outer Diameter5.5Millimeter

Contacts#

Phone, Email table
PhoneEmail
417-689-2424info@allumin8.com

Regulatory Flags#

DUNS number
121774080
Device count
1
Lot or batch
true
Expiration date on label
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
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
20850062071210A8 INTEGR8® Porous Pedicle Screw SystemA8-65-0060-1A8-65-0060-12026-05-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840466901011PrimusSPINAL ELEMENTS, INC.NKB2026-10-22
00840606174855PrimusSPINAL ELEMENTS, INC.NKB2026-10-22
00840606175142PrimusSPINAL ELEMENTS, INC.NKB2026-10-22
00840606175203PrimusSPINAL ELEMENTS, INC.NKB2026-10-22
00840606185868PrimusSPINAL ELEMENTS, INC.NKB2026-10-22
03701313009823KHEIRONS.M.A.I.ONKB2026-10-22
03701313009830KHEIRONS.M.A.I.ONKB2026-10-22
03701313009854KHEIRONS.M.A.I.ONKB2026-10-22
03701313009878KHEIRONS.M.A.I.ONKB2026-10-22
03701313009885KHEIRONS.M.A.I.ONKB2026-10-22
03701313009892KHEIRONS.M.A.I.ONKB2026-10-22
03701313009908KHEIRONS.M.A.I.ONKB2026-10-22
00197157123611ZAVATION SCREWZavation LLCNKB2026-10-21
00197157123628ZAVATION SCREWZavation LLCNKB2026-10-21
00197157123635ZAVATION SCREWZavation LLCNKB2026-10-21
00197157123642ZAVATION SCREWZavation LLCNKB2026-10-21
00197157123659ZAVATION SCREWZavation LLCNKB2026-10-21
00197157123666ZAVATION SCREWZavation LLCNKB2026-10-21
00197157122874ZAVATION SCREWZavation LLCNKB2026-10-20
00197157122881ZAVATION SCREWZavation LLCNKB2026-10-20
00197157122898ZAVATION SCREWZavation LLCNKB2026-10-20
00197157122904ZAVATION SCREWZavation LLCNKB2026-10-20
00197157122911ZAVATION SCREWZavation LLCNKB2026-10-20
00197157122928ZAVATION SCREWZavation LLCNKB2026-10-20
00197157122935ZAVATION SCREWZavation LLCNKB2026-10-20
00197157122942ZAVATION SCREWZavation LLCNKB2026-10-20
00197157122959ZAVATION SCREWZavation LLCNKB2026-10-20
00197157122966ZAVATION SCREWZavation LLCNKB2026-10-20
00197157122973ZAVATION SCREWZavation LLCNKB2026-10-20
00197157122980ZAVATION SCREWZavation LLCNKB2026-10-20