Skip to content

YUKON OCT Spinal System 7601-04522T

by VB Spine LLC FDA registration: United States GUDID

Product code NKG

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10888857590335 UDI-DIDate7 Nov 2025ListedStatusIn distribution

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — GUDID listing Listed

Recalls

1 recall · FDA

    • Terminated Z-0520-2021 FDA Class II initiated 3 Nov 2020

    Shafts do not pass through the inner cannula of the Anti-Torque Alignment Tube from Lot KTGG due to a manufacturing nonconformance. This could result in a delay of surgery or result in surgical intervention later on.

Specification

GUDID · synced 23 Oct 2026

Trade Name
YUKON OCT Spinal System
Generic Name
Spinal bone screw, non-bioabsorbable
Model / Ref / Catalog
7601-04522T
Primary DI / UDI-DI
10888857590335
510(k) Number
FDA Product Code
NKG, KWP
GMDN Term
Spinal bone screw, non-bioabsorbable
Device Class
Class II
Regulation Number
888.3075, 888.3050
Commercial Distribution
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization
MRI Safety
MR Conditional
Size
Outer Diameter — 4.5 Millimeter
Length — 22 Millimeter

Related devices

Cleared under the same submission (K193129)

Show all (12)

Cleared under the same submission (K242361)

Show all (12)

Other devices from VB Spine LLC

See all devices from VB Spine LLC →

Properties & raw data

Show properties, registry sources and raw records
  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number
Other properties (10)
  • Sterile: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No

Sources (1)

  • FDA UDI d24e69db-a4c5-413e-a860-c3e283aa63d3 37 fields · synced 23 Oct 2026