AccessGUDID - DEVICE: MaxAn Anterior Cervical Plate System (03662663145138)

GUDID

Device Identifier (DI) Information

Brand Name: MaxAn Anterior Cervical Plate System
Version or Model: 14-522476E
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 14-522476E
Company Name: Highridge Medical, LLC

Primary DI Number: 03662663145138
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 119260394 *Terms of Use

Device Description: 4 LEVEL 76MM FIXED PLATE

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?
46653	Spinal fixation plate, non-bioabsorbable	A small, implantable, non-customized sheet of solid material intended to be attached to the spine with screws for spinal immobilization as part of treatment of a spinal instability or deformity; it is made of a material that is not chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). Disposable instruments intended to facilitate implantation, or fixation implants (i.e., bone screws), may be packaged with the plate.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
KWQ	Appliance, fixation, spinal intervertebral body

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---4 LEVEL 76MM FIXED PLATE

Device Record Status

Public Device Record Key: 525df79b-8550-4d09-9b96-7152f0547405
Public Version Date: November 28, 2025
Public Version Number: 1
DI Record Publish Date: November 20, 2025