Model: 16-57-41000
Catalog: 16-57-41000
DI: 07640172554227
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-04-30
Current Version: 2026-05-08
Description
VADER Pedicle System, Nut Screw, Ti
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
78835d68-71c4-47c0-b493-8fe184f30d5c
Distribution Status:
In Commercial Distribution
DUNS Number:
480789465
Device Count:
1
DM Exempt:
Yes
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:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
07640172554227
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 61670
Name: Implantable bone washer
Definition:
An implantable, flat ring or plate designed to be used with a nut and bolt/screw to improve tightness in an orthopaedic, spinal, and/or craniofacial bone fixation assembly. It may be made of metal, polymer, or reinforced polymer. This is a single-use device.
FDA Product Codes
NKB
Thoracolumbosacral Pedicle Screw System
PML
Bone Cement, Posterior Screw Augmentation