Device
A8 INTEGR8 Cannulated Fenestrated Porous Pedicle Screw - 1PK, Ø7.5x30mm
Manufacturer
ALLUMIN8, INC.
ALLUMIN8, INC.
Model: A8-75-0030-1
Catalog: A8-75-0030-1
DI: 20850062071296
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, Ø7.5x30mm
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
663f5533-a0a1-4322-a533-09d3e7055b3a
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:
20850062071296
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:
7.5
Item #1 - Size Type:
Outer Diameter
Item #2 - Size - @attributes - Unit:
Millimeter
Item #2 - Size - @attributes - Value:
30
Item #2 - Size Type:
Length