Device
Single-use non-sterile implantable low profile tapered grub screw intended for posterior spinal fixation systems.
Manufacturer
TITAMED (PTY) LTD
TITAMED (PTY) LTD
Model: LGT
Catalog: LGT
DI: 06009699901791
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 low profile tapered grub screw 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:
5979da32-c8f7-4692-9b99-2c53ef100dd8
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:
06009699901791
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 66948
Name: Spinal bone screw head/rod adaptor
Definition:
A small, implantable, non-bioabsorbable device intended to be attached to the top end of a spinal screw (not included) typically to secure/stabilize a rod and/or connector as part of an internal spinal fixation procedure. Also known as a reduction head or tulip, it is typically U-shaped with threads to receive a set screw and/or has a hole to allow the rod and/or connector to pass through; it may also facilitate a degree of motion. It is available in various lengths and is made of metal (e.g., surgical steel, titanium alloy) and/or synthetic polymer materials.
FDA Product Codes
NKB
Thoracolumbosacral Pedicle Screw System
Premarket Submissions
Submission Number:
K070385
Supplement Number:
000