FDA.reportPublic FDA data

A8 INTEGR8® Porous Pedicle Screw System

Primary DI
00850062071421
Brand
A8 INTEGR8® Porous Pedicle Screw System
Company
ALLUMIN8, INC.
Model
A8-80-0060
Catalog number
A8-80-0060
Device description
A8 INTEGR8 Cannulated Fenestrated Porous Pedicle Screw Ø8.0x60mm
Published
2026-02-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
10850062071428PrimaryGS10
00850062071421Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085006207142810850062071428
00850062071421008500620714218500620714210850062071421

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
Length60Millimeter
Outer Diameter8Millimeter

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
121774080
Device count
2
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
03700780634583Erisma®-LPCLARIANCENKB2026-05-28
06009699900008Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900503Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900817Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900831Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900848Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900855Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900862Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900879Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900886Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900893Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900909Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900916Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900923Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900930Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900947Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900954Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900961Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900978Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900985Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900992Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699901005Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699901012Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699901029Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699901036Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699901043Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699901050Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699901067Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699901074Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699901081Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28