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510(k) K101993

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

K101993 is an FDA 510(k) premarket notification submitted by Depuy Spine, Inc. for the device "VIPER SYSTEM, EXPEDIUM SYSTEM". The FDA issued a decision of Substantially Equivalent on December 7, 2010. 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
SESE (Substantially Equivalent)
Decision Date
December 7, 2010
Date Received
July 15, 2010
Clearance Type
Special
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)
  • K111136 — EXPEDIUM SPINE SYSTEM, VIPER SYSTEM, VIPER 2 SYSTEM (June 14, 2012)
  • 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)
  • 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