FDA.reportPublic FDA data

A8 INTEGR8® Porous Pedicle Screw System

Primary DI
00850062071209
Brand
A8 INTEGR8® Porous Pedicle Screw System
Company
ALLUMIN8, INC.
Model
A8-65-0055
Catalog number
A8-65-0055
Device description
A8 INTEGR8 Cannulated Fenestrated Porous Pedicle Screw Ø6.5x55mm
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
10850062071206PrimaryGS10
00850062071209Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085006207120610850062071206
00850062071209008500620712098500620712090850062071209

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
Length55Millimeter
Outer Diameter6.5Millimeter

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
00850062071001A8 INTEGR8® Porous Pedicle Screw SystemA8-00-CAPA8-00-CAP2026-02-27
00850062071506A8 INTEGR8® Porous Pedicle Screw SystemRST-55-0025RST-55-00252026-02-27
00850062071513A8 INTEGR8® Porous Pedicle Screw SystemRST-55-0030RST-55-00302026-02-27
00850062071520A8 INTEGR8® Porous Pedicle Screw SystemRST-55-0035RST-55-00352026-02-27
00850062071537A8 INTEGR8® Porous Pedicle Screw SystemRST-55-0040RST-55-00402026-02-27
00850062071544A8 INTEGR8® Porous Pedicle Screw SystemRST-55-0045RST-55-00452026-02-27
00850062071551A8 INTEGR8® Porous Pedicle Screw SystemRST-55-0050RST-55-00502026-02-27
00850062071568A8 INTEGR8® Porous Pedicle Screw SystemRST-55-0055RST-55-00552026-02-27
00850062071575A8 INTEGR8® Porous Pedicle Screw SystemRST-55-0060RST-55-00602026-02-27
00850062071582A8 INTEGR8® Porous Pedicle Screw SystemRST-55-0065RST-55-00652026-02-27
00850062071599A8 INTEGR8® Porous Pedicle Screw SystemRST-55-0070RST-55-00702026-02-27
00850062071605A8 INTEGR8® Porous Pedicle Screw SystemRST-55-0075RST-55-00752026-02-27
00850062071612A8 INTEGR8® Porous Pedicle Screw SystemRST-55-0080RST-55-00802026-02-27
00850062071629A8 INTEGR8® Porous Pedicle Screw SystemRST-55-0085RST-55-00852026-02-27
00850062071636A8 INTEGR8® Porous Pedicle Screw SystemRST-55-0090RST-55-00902026-02-27
00850062071643A8 INTEGR8® Porous Pedicle Screw SystemRST-55-0095RST-55-00952026-02-27
00850062071650A8 INTEGR8® Porous Pedicle Screw SystemRST-55-0100RST-55-01002026-02-27
00850062071667A8 INTEGR8® Porous Pedicle Screw SystemRST-55-0110RST-55-01102026-02-27
00850062071674A8 INTEGR8® Porous Pedicle Screw SystemRST-55-0120RST-55-01202026-02-27
00850062071681A8 INTEGR8® Porous Pedicle Screw SystemRST-55-0130RST-55-01302026-02-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
008401853825664CIS WILL PEDICLE SCREW SYSTEMSOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITEDNKB2026-05-25
008401853825734CIS WILL PEDICLE SCREW SYSTEMSOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITEDNKB2026-05-25
008401853825804CIS WILL PEDICLE SCREW SYSTEMSOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITEDNKB2026-05-25
008401853825974CIS WILL PEDICLE SCREW SYSTEMSOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITEDNKB2026-05-25
07290014381254ProMIS™ Fixation SystemPREMIA SPINE LTDNKB2026-05-25
07290014381261ProMIS™ Fixation SystemPREMIA SPINE LTDNKB2026-05-25
07290115935615Counter Torque STPREMIA SPINE LTDNKB2026-05-25
06941312465757Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-24
06941312465764Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-24
06941312465771Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-24
06941312465788Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-24
06941312465795Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-24
06941312465801Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-24
06941312465818Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-24
06941312465825Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-24
06941312465832Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-24
06941312465849Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-24
06941312465856Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-24
06941312465887Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-24
06941312465894Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-24
06941312465900Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-24
06941312465559Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-22
06941312465566Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-22
06941312465573Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-22
06941312465580Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-22
06941312465597Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-22
06941312465603Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-22
06941312465610Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-22
06941312465627Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-22
06941312465634Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-22