FDA.reportPublic FDA data

A8 INTEGR8® Porous Pedicle Screw System

Primary DI
00850080772911
Brand
A8 INTEGR8® Porous Pedicle Screw System
Company
ALLUMIN8, INC.
Model
A8NS-002-0012
Catalog number
A8NS-002-0012
Device description
Straight Ratcheting Handle - 1/4 SQ
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
00850080772911PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850080772911008500807729118500807729110850080772911

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument handle, non-torque-limitingA hand-held manual surgical instrument designed to attach to the proximal end of a surgical instrument (e.g., a screwdriver shaft) to allow the surgeon to perform manipulations with the instrument, such as manual rotation of a bone screw or reamer; it does not include a torque-limiting function. The device is typically made of metal and/or synthetic material and may have a straight or T-shaped handle grip which may include additional features such as a ratchet mechanism to allow the surgeon to maintain a constant hold on the handle when providing rotation in one direction. 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

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