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510(k) K113666

XIA 3 SPINAL SYSTEM by Stryker Spine — Product Code NKB

K113666 is an FDA 510(k) premarket notification submitted by Stryker Spine for the device "XIA 3 SPINAL SYSTEM". The FDA issued a decision of SESU on August 28, 2012. The device falls under product code NKB (Thoracolumbosacral Pedicle Screw System), a Class II device regulated under 21 CFR 888.3070. Stryker Spine has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESU ()
Decision Date
August 28, 2012
Date Received
December 13, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Thoracolumbosacral Pedicle Screw System
Device Class
Class II
Regulation Number
888.3070
Review Panel
OR
Submission Type

Intended to provide immobilization and stabilization of spinal segments in thoracic, lumbar, and sacral spine as an adjunct to fusion.

Other clearances by Stryker Spine

  • K262061 — Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Po (July 17, 2026)
  • K261008 — Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip; Vitoss® BiModal Bioa (April 24, 2026)
  • K242361 — OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal Sy (November 7, 2024)
  • K242280 — Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip, Vitoss® BiModal Bioa (August 29, 2024)
  • K222684 — XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serr (June 8, 2023)
  • K221490 — Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Poste (February 14, 2023)
  • K203205 — Navigated Spine Instruments (March 23, 2021)
  • K200666 — Stryker Xia 3 Power Adaptor (April 23, 2020)
  • K183249 — Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curve (July 25, 2019)
  • K183071 — VLIFT-s Vertebral Body Replacement System (January 10, 2019)

Other clearances for product code NKB

  • K262091 — FRAXION Spinal Fixation System (September 17, 2026)
  • K262193 — RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor (September 14, 2026)
  • K262828 — KHEIRON® Spinal Fixation System, including patient specific K-ROD (September 4, 2026)
  • K253943 — Tiger 2 System (July 24, 2026)
  • K260362 — QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Co (July 24, 2026)
  • K261284 — Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation Sy (July 14, 2026)
  • K253802 — KHEIRON® Spinal Fixation System, including patient specific K-ROD (July 1, 2026)
  • K253045 — “Socko” Vimax Spinal Fixation System (June 17, 2026)
  • K251251 — ChanPin Pedicle Screw Spinal System (June 9, 2026)
  • K260989 — Varion Thoracolumbar Fixation System (May 15, 2026)

FDA data resources