Device
Guidewire 1.5mmx500mm Blunt Tip Threaded
Manufacturer
Xtant Medical Holdings, Inc.
Model: 51-GW-500-BLUNT-TH Catalog: 51-GW-500-BLUNT-TH DI: 00840311246779 Status: New MRI: Labeling does not contain MRI Safety Information Single-use: No Rx: Yes OTC: No
First Published: 2026-04-30 Current Version: 2026-05-08
Description
Guidewire 1.5mmx500mm Blunt Tip Threaded
Sterilization
Method Types - Sterilization Method: Moist Heat or Steam Sterilization
Device Sterile: No
Sterilization Prior To Use: Yes
Regulatory & Distribution
Record Status: Published
Version Number: 1
Record Key: 40feb35a-25ec-42ff-bb38-60ba034240a5
Distribution Status: In Commercial Distribution
DUNS Number: 081224143
Device Count: 1
DM Exempt: No
Premarket Exempt: No
HCT/P: No
Kit: No
Combination Product: No
Lot/Batch Tracked: Yes
Serial Number Tracked: No
Manufacturing Date Tracked: No
Expiration Date Tracked: No
Donation ID Number Tracked: No
Labeled Contains NRL: No
Labeled No NRL: No
Identifiers
Item #1 - Device ID: 00840311246779
Item #1 - Device ID Type: Primary
Item #1 - Device ID Issuing Agency: GS1
Item #2 - Device ID: 00846468056506
Item #2 - Device ID Type: Previous
Item #2 - Device ID Issuing Agency: GS1
GMDN
Code: 63819
Name: Spinal guidewire
Definition:
A thin, non-implantable rod intended to guide the insertion of a cannulated orthopaedic implant (typically a screw) and/or surgical instrument (e.g., cannula, drill bit) during spinal surgery. This is a single-use device.
FDA Product Codes
MNI
Orthosis, spinal pedicle fixation
MNH
Orthosis, spondylolisthesis spinal fixation
Premarket Submissions
Submission Number: K130286
Supplement Number: 000