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510(k) K160226

JAZZ CLAW System (hooks and rods) and JAZZ CLAW connector by Implanet, S.A. — Product Code NKB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 18, 2016
Date Received
January 29, 2016
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 Implanet, S.A.

  • K254017 — SWINGO-3D Lumbar Cage System (February 26, 2026)
  • K252437 — JAZZ Spinal System (August 28, 2025)
  • K240392 — JAZZ Spinal System (May 6, 2024)
  • K230026 — SQUALE (March 28, 2023)
  • K192084 — Madison Total Knee System (October 22, 2019)
  • K191217 — JAZZ PF (August 2, 2019)
  • K182771 — ISS-JAZZ Screw System and JAZZ CAP SP (March 12, 2019)
  • K171881 — JAZZ Passer Band (August 8, 2017)
  • K170730 — JAZZ System, including JAZZ Band (June 9, 2017)
  • K162764 — JAZZ FRAME SYSTEM (January 19, 2017)

Other clearances for product code NKB

  • K254247 — OSTEOMNI SPINAL FIXATION SYSTEM (February 24, 2026)
  • K253169 — Duet™ Spinal Fixation System (February 23, 2026)
  • 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)