Device
A8 INTEGR8 Cannulated Fenestrated Porous Pedicle Screw - 1PK, Ø6.5x55mm
Manufacturer
ALLUMIN8, INC.
Model: A8-65-0055-1 Catalog: A8-65-0055-1 DI: 20850062071203 Status: New MRI: Labeling does not contain MRI Safety Information Single-use: Yes Rx: Yes OTC: No
First Published: 2026-05-15 Current Version: 2026-05-25
Description
A8 INTEGR8 Cannulated Fenestrated Porous Pedicle Screw - 1PK, Ø6.5x55mm
Sterilization
Device Sterile: Yes
Sterilization Prior To Use: No
Regulatory & Distribution
Record Status: Published
Version Number: 1
Record Key: 65855f67-2d52-408d-bc3f-958aac5c96ec
Distribution Status: In Commercial Distribution
DUNS Number: 121774080
Device Count: 1
DM Exempt: No
Premarket Exempt: No
HCT/P: No
Kit: No
Combination Product: No
Lot/Batch Tracked: Yes
Serial Number Tracked: No
Manufacturing Date Tracked: No
Expiration Date Tracked: Yes
Donation ID Number Tracked: No
Labeled Contains NRL: No
Labeled No NRL: No
Identifiers
Device ID: 20850062071203
Type: Primary
Issuing Agency: GS1
GMDN
Code: 46651
Name: Spinal bone screw, non-bioabsorbable
Definition:
A 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.
FDA Product Codes
NKB
Thoracolumbosacral Pedicle Screw System
Premarket Submissions
Submission Number: K242827
Supplement Number: 000
Device Sizes
Item #1 - Size - @attributes - Unit: Millimeter
Item #1 - Size - @attributes - Value: 6.5
Item #1 - Size Type: Outer Diameter
Item #2 - Size - @attributes - Unit: Millimeter
Item #2 - Size - @attributes - Value: 55
Item #2 - Size Type: Length