AccessGUDID - DEVICE: Alpine XC Adjustable Fusion System (03662663197830)

GUDID

Device Identifier (DI) Information

Brand Name: Alpine XC Adjustable Fusion System
Version or Model: 6303-1113
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 6303-1113
Company Name: Highridge Medical, LLC

Primary DI Number: 03662663197830
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 119260394 *Terms of Use

Device Description: Adjust. Post Plate 10-18 XNrw OB

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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?
61533	Interspinous spinal fixation implant	An implantable device intended to be attached to two adjacent vertebral spinous processes to provide immobilization and stabilization of spinal segments as an adjunct to bony fusion in the treatment of spinal conditions (e.g., degenerative disc disease, spondylolisthesis, tumour, trauma). It is intended to be used on the thoracic, lumbar or sacral spine during a minimally-invasive procedure. It is made of metal [e.g., titanium (Ti), nickel-titanium alloy (Nitinol)] and may incorporate bone graft pockets. This is a single-use device.	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: 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
Device Size Text, specify: Device Size Text, specify---Adjust. Post Plate 10-18 XNrw OB

Device Record Status

Public Device Record Key: 6aa4efcf-03f2-4035-8c69-7b49fa4be8fe
Public Version Date: December 25, 2025
Public Version Number: 1
DI Record Publish Date: December 17, 2025