Device
Single-use non-sterile implantable universal-marla rod-extension intended for posterior spinal fixation systems.
Manufacturer
TITAMED (PTY) LTD
TITAMED (PTY) LTD
Model: MCON
Catalog: MCON
DI: 06009699901807
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 universal-marla rod-extension 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:
1698ead7-7abe-4229-9975-7f4bc6685586
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:
06009699901807
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 67285
Name: Spinal rachet-distraction rod extender
Definition:
An implantable, metallic device in the form of a short, fixed length rod intended to be optionally connected to the upper end of a mechanical rachet-based spinal distraction rod (not included) to increase its length to provide greater load distribution (e.g., when the patient has small pedicles) as part of scoliosis treatment. It is not intended to be implanted without the parent rod. It has a U-shaped end, which may be straight or angled, to allow connection to the parent rod; it is designed to be fixed to the parent rod and vertebrae using bone screws.
FDA Product Codes
NKB
Thoracolumbosacral Pedicle Screw System
Premarket Submissions
Submission Number:
K070385
Supplement Number:
000