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510(k) K231769

activL® Next Generation Instrumentation by Aesculap Implants Systems, LLC — Product Code QLQ

K231769 is an FDA 510(k) premarket notification submitted by Aesculap Implants Systems, LLC for the device "activL® Next Generation Instrumentation". The FDA issued a decision of Substantially Equivalent on July 13, 2023. 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. Aesculap Implants Systems, LLC has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 13, 2023
Date Received
June 16, 2023
Clearance Type
Special
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 Aesculap Implants Systems, LLC

  • K172235 — CoreHip® System (March 28, 2018)
  • K172032 — Modulift Vertebral Body Replacement (VBR) System (November 20, 2017)
  • K143443 — VEGA Knee System, Columbus Total Knee System (March 25, 2015)

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)
  • 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