FDA.reportPublic FDA data

A8 INTEGR8® Porous Pedicle Screw System

Primary DI
00850080774243
Brand
A8 INTEGR8® Porous Pedicle Screw System
Company
ALLUMIN8, INC.
Model
A8CT-001-0005
Catalog number
A8CT-001-0005
Device description
Ø6.0mm Titanium Rod Caddy
Published
2026-05-15
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
FSMTray, Surgical, Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850080774243PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850080774243008500807742438500807742430850080774243

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tray, reusableA container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
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

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Primary DI, Brand, Company table
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07640221370860SCALASpineArt SAFSM2026-07-24
00190776421991MillenniumAvalign Technologies, Inc.FSM2026-07-23
00190776422004MillenniumAvalign Technologies, Inc.FSM2026-07-23
18059015378368Flexible Reamers SystemORTHOFIX SRLFSM2026-07-23
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B803PW6G0ORTHOMEDORTHO-MED, INC.FSM2026-07-22
00840606195737ViaductSPINAL ELEMENTS, INC.FSM2026-07-20
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