AccessGUDID - DEVICE: Timberline Lateral Fusion System (03662663277686)

GUDID

Device Identifier (DI) Information

Brand Name: Timberline Lateral Fusion System
Version or Model: 8738-0501
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 8738-0501
Company Name: Highridge Medical, LLC

Primary DI Number: 03662663277686
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 119260394 *Terms of Use

Device Description: ANCHORING PIN 50MM BLADE

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?
66938	Spinal intraoperative positioning screw	A nonimplantable threaded rod with a screw head and an internal (socket) drive intended to be temporarily screwed into vertebral bone to assist with the positioning of an implantable device (typically a fixation plate) during spinal surgery. The internal drive may be one of a variety of designs (e.g., a slot, or of cross, star, or polygonal shape) for use with an appropriate screwdriver. Once introduced it does not include a rod that protrudes from the vertebral bone (i.e., not a positioning/manipulation pin). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LXH	Orthopedic manual surgical instrument

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

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

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 49a870c7-d243-4f45-b625-c45dca013d86
Public Version Date: March 19, 2026
Public Version Number: 2
DI Record Publish Date: December 18, 2025