Device
Single-use non-sterile implantable cap cross-connector intended for posterior spinal fixation systems.
Manufacturer
TITAMED (PTY) LTD
Model: XCON-03 Catalog: XCON-03 DI: 06009699902996 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 cap cross-connector 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: 791321ba-5827-43c1-ac2f-6b4f1612195a
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: 06009699902996
Type: Primary
Issuing Agency: GS1
GMDN
Code: 65114
Name: Bone-screw internal spinal fixation system connector
Definition:
An implantable, small connecting component of a bone-screw internal spinal fixation system typically in the form of a thin band or small rod with a groove or hole at one or both ends, into which the screw heads and/or primary rods fit, 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)]. It is designed as a transverse or longitudinal connecting element to be attached to the corresponding screw heads and/or primary rods; it may also have adjustable length and/or angle and/or allow a small amount of screw/rod movement.
FDA Product Codes
NKB
Thoracolumbosacral Pedicle Screw System
Premarket Submissions
Submission Number: K070385
Supplement Number: 000