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510(k) K242869

prodisc® L Instruments by Centinel Spine, LLC — Product Code QLQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 2024
Date Received
September 20, 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 by Centinel Spine, LLC

  • K250554 — prodisc® L Instruments (April 25, 2025)
  • K221848 — prodisc C SK, prodisc C Nova, and prodisc C Vivo Instruments (August 19, 2022)
  • K173347 — STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF (May 8, 2018)
  • K152211 — PCT System (December 1, 2015)
  • K150053 — STALIF C; STALIF C-Ti (June 24, 2015)
  • K150643 — Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-Ti (June 8, 2015)
  • K141942 — MIDLINE II TI (November 7, 2014)
  • K142079 — STALIF CTI, STALIF C (October 24, 2014)
  • K133200 — STALIF C(R) (May 8, 2014)
  • K133286 — MIDLINE (TM) (January 9, 2014)

Other clearances for product code QLQ

  • K250554 — prodisc® L Instruments (April 25, 2025)
  • 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)
  • K220861 — M6-C Artificial Cervical Disc Instruments AS (June 2, 2022)
  • K211757 — Simplify Disc (August 20, 2021)