Home / 510(k) Clearances / K241117

510(k) K241117

M6-C™ Single Use, Disposable Instrumentation by Spinal Kinetics / Orthofix / Seaspine — Product Code QLQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 21, 2024
Date Received
April 23, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Manual Instruments Designed For Use With Total Disc Replacement Devices
Device Class
Class II
Regulation Number
888.4515
Review Panel
OR
Submission Type

The devices are intended to manipulate tissue or implant materials for the positioning, alignment, defect creation, placement, or removal of total disc replacement devices.

Other clearances for product code QLQ

  • K250554 — prodisc® L Instruments (April 25, 2025)
  • K242869 — prodisc® L Instruments (December 17, 2024)
  • K231769 — activL® Next Generation Instrumentation (July 13, 2023)
  • K221848 — prodisc C SK, prodisc C Nova, and prodisc C Vivo Instruments (August 19, 2022)
  • K220861 — M6-C Artificial Cervical Disc Instruments AS (June 2, 2022)
  • K211757 — Simplify Disc (August 20, 2021)