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510(k) K111136

EXPEDIUM SPINE SYSTEM, VIPER SYSTEM, VIPER 2 SYSTEM by Depuy Spine, Inc. — Product Code NKB

K111136 is an FDA 510(k) premarket notification submitted by Depuy Spine, Inc. for the device "EXPEDIUM SPINE SYSTEM, VIPER SYSTEM, VIPER 2 SYSTEM". The FDA issued a decision of SESU on June 14, 2012. The device falls under product code NKB (Thoracolumbosacral Pedicle Screw System), a Class II device regulated under 21 CFR 888.3070. Depuy Spine, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESU ()
Decision Date
June 14, 2012
Date Received
April 22, 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 Depuy Spine, Inc.

  • K222276 — CONDUIT Cages; FIBERGRAFT BG Putty (October 15, 2022)
  • K201831 — CONFIDENCE Spinal Cement System (August 31, 2020)
  • K142185 — EXPEDIUM VERSE SPINE SYSTEM (November 19, 2014)
  • K121020 — VIPER SYSTEM (May 3, 2012)
  • K110353 — MOUNTAINEER OCT SPINAL SYSTEM (April 7, 2011)
  • K110216 — EXPEDIUM SYSTEM, VIPER SYSTEM (April 1, 2011)
  • K103133 — VEPER SYSTEM, EXPEDIUM SYSTEM (January 18, 2011)
  • K101993 — VIPER SYSTEM, EXPEDIUM SYSTEM (December 7, 2010)
  • K101923 — CONCORDE CURVE SYSTEM (December 1, 2010)
  • K103100 — MOUNTAINEER OCT SPINAL SYSTEM (November 17, 2010)

Other clearances for product code NKB

  • 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)
  • K253739 — SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® (May 7, 2026)
  • K261130 — AccelFix Spinal Fixation System (May 5, 2026)
  • K253966 — PERLA® TL Posterior Thoraco-lumbar Fixation System (May 1, 2026)
  • K252542 — LEO Spinal System (April 29, 2026)
  • K253940 — M.U.S.T. Pedicle Screw System - Extension (April 28, 2026)

FDA data resources