AccessGUDID - DEVICE: Vital Spinal Fixation System (03662663216296)

GUDID

Device Identifier (DI) Information

Brand Name: Vital Spinal Fixation System
Version or Model: 732M2126
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 732M2126
Company Name: Highridge Medical, LLC

Primary DI Number: 03662663216296
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 119260394 *Terms of Use

Device Description: Posterior Wall Impactor 26 mm

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?
32856	Orthopaedic implant impactor, reusable	A non-powered, hand-held, surgical instrument designed to transmit impact forces, typically from a hammer/mallet to an orthopaedic implant (e.g., intramedullary nail or stem), to position/drive the implant into the body during impact-based implantation. It commonly includes an impact-absorbing handle with a distal end shaped to conform to the implant (i.e., flat or anatomically curved). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HWA	IMPACTOR

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
Device Size Text, specify: Device Size Text, specify---Posterior Wall Impactor 26 mm

Device Record Status

Public Device Record Key: 6c8ff0e2-cf27-465f-b42b-b2730fad6667
Public Version Date: February 09, 2026
Public Version Number: 2
DI Record Publish Date: December 17, 2025