Model: 03.47.014
DI: 07630542758324
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-04
Current Version: 2026-05-12
Description
Angled Hook Left (Ø5.5-6)
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
ae95ed33-6e4f-453a-bb4f-cf649900f6ce
Distribution Status:
In Commercial Distribution
DUNS Number:
488227125
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:
07630542758324
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 65115
Name: Bone-screw internal spinal fixation system hook
Definition:
An implantable component of a bone-screw internal spinal fixation system that has a curved (hook-shaped) design intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, and also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. This component is typically made of metal [e.g., titanium (Ti)] and placed/hooked around the lamina or pedicle of a vertebra, without penetration (i.e., not a screw), to provide a stable connection for the system’s rod; the rod is typically stabilized in the U-shaped hook head with a small lid or screw.
FDA Product Codes
NKB
Thoracolumbosacral pedicle screw system
Premarket Submissions
Submission Number:
K253940
Supplement Number:
000