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510(k) K241117

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

K241117 is an FDA 510(k) premarket notification submitted by Spinal Kinetics / Orthofix / Seaspine for the device "M6-C™ Single Use, Disposable Instrumentation". The FDA issued a decision of Substantially Equivalent on June 21, 2024. The device falls under product code QLQ (Manual Instruments Designed For Use With Total Disc Replacement Devices), a Class II device regulated under 21 CFR 888.4515.

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

  • K262639 — BAGUERA® C Cervical Disc Surgical Instruments (August 14, 2026)
  • K253392 — Synergy Disc Instruments (March 27, 2026)
  • 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)

FDA data resources