Device
Single-use non-sterile implantable large straight tapered laminar hook intended for posterior spinal fixation systems.
Manufacturer
TITAMED (PTY) LTD
TITAMED (PTY) LTD
Model: HL8S-T
Catalog: HL8S-T
DI: 06009699901777
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-28
Current Version: 2026-06-05
Description
Single-use non-sterile implantable large straight tapered laminar hook intended for posterior spinal fixation systems.
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:
16295459-a17e-41c9-8080-a8d29576370d
Distribution Status:
In Commercial Distribution
DUNS Number:
635580744
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:
06009699901777
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:
K070385
Supplement Number:
000