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510(k) K071495

EXPEDIUM 4.5MM SPINE SYSTEM by Depuy Spine, A Johnson & Johnson Company — Product Code NKB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 29, 2007
Date Received
May 31, 2007
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, A Johnson & Johnson Company

  • K131802 — EXPEDIUM, VIPER. VIPER 2 SPINE SYSTEM (September 12, 2013)
  • K102249 — EXPEDIUM SPINE SYSTEM (December 16, 2010)
  • K071927 — MODIFICATION TO VERTEBROPLASTIC RADIOPAQUE BONE CEMENT (November 21, 2007)

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  • K253545 — Vulcan Spinal System (February 10, 2026)
  • K252461 — Swedge™ Pedicle Screw Fixation System Bezier Rod (January 13, 2026)
  • K253990 — KHEIRON® Spinal Fixation System, including patient specific K-ROD (January 7, 2026)
  • K253941 — CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly) (January 7, 2026)
  • K253093 — Vital™ Spinal Fixation System (December 17, 2025)
  • K253721 — KHEIRON® Spinal Fixation System, including patient specific K-ROD (December 17, 2025)
  • K252729 — Universal Spinal System (November 18, 2025)
  • K253335 — CD Horizon™ Spinal System (October 24, 2025)