AccessGUDID - DEVICE: Lineum Occipito-Cervico-Thoracic (OCT) Spinal Fixation System (03662663147170)

GUDID

Device Identifier (DI) Information

Brand Name: Lineum Occipito-Cervico-Thoracic (OCT) Spinal Fixation System
Version or Model: 14-524036E
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 14-524036E
Company Name: Highridge Medical, LLC

Primary DI Number: 03662663147170
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 119260394 *Terms of Use

Device Description: LINEUM 6.0MM THROAT LH HOOK

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
65115	Bone-screw internal spinal fixation system hook	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.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
KWP	APPLIANCE, FIXATION, SPINAL INTERLAMINAL

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Device Size Text, specify---LINEUM 6.0MM THROAT LH HOOK

Device Record Status

Public Device Record Key: 629382e1-86a3-47b8-8d09-5d759728851f
Public Version Date: November 28, 2025
Public Version Number: 1
DI Record Publish Date: November 20, 2025