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510(k) K220861

M6-C Artificial Cervical Disc Instruments AS by Spinal Kinetics, LLC — Product Code QLQ

K220861 is an FDA 510(k) premarket notification submitted by Spinal Kinetics, LLC for the device "M6-C Artificial Cervical Disc Instruments AS". The FDA issued a decision of Substantially Equivalent on June 2, 2022. 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 2, 2022
Date Received
March 24, 2022
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)
  • K241117 — M6-C™ Single Use, Disposable Instrumentation (June 21, 2024)
  • K231769 — activL® Next Generation Instrumentation (July 13, 2023)
  • K221848 — prodisc C SK, prodisc C Nova, and prodisc C Vivo Instruments (August 19, 2022)
  • K211757 — Simplify Disc (August 20, 2021)

FDA data resources