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510(k) K162367

Erisma® LP MIS by Clariance, Sas — Product Code NKB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 27, 2016
Date Received
August 23, 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 Clariance, Sas

  • K243904 — Elegance® Anterior Cervical plate (January 14, 2025)
  • K243670 — Idys® LIF (December 31, 2024)
  • K241863 — Erisma® Lp Spinal Fixation System; Erisma® LP MIS (July 24, 2024)
  • K240872 — Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation System (April 26, 2024)
  • K240715 — Idys® C ZP 3DTi (March 22, 2024)
  • K220182 — Aggeris™-C (March 30, 2022)
  • K212562 — Idys-C ZP 3DTi (October 12, 2021)
  • K200919 — Idys ALIF 3DTi (April 12, 2021)
  • K202032 — Idys LLIF 3DTi (April 1, 2021)
  • K202956 — Erisma LP Navigated Instruments (February 26, 2021)

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)