Model: 11010530
Catalog: 11010530
DI: 00887517156822
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: No
First Published: 2026-04-25
Current Version: 2026-05-04
Description
GSB Screw, 10.5x30mm 2S Polyaxial
Sterilization
Method Types - Sterilization Method:
Moist Heat or Steam Sterilization
Device Sterile:
No
Sterilization Prior To Use:
Yes
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
a36b853e-f9ec-44c8-9207-42755307cd49
Distribution Status:
In Commercial Distribution
DUNS Number:
053950783
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:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00887517156822
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
MNI
Orthosis, spinal pedicle fixation
KWP
APPLIANCE, FIXATION, SPINAL INTERLAMINAL
MNH
Orthosis, spondylolisthesis spinal fixation
KWQ
Appliance, fixation, spinal intervertebral body
NKB
Thoracolumbosacral pedicle screw system
Premarket Submissions
Submission Number:
K132014
Supplement Number:
000