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510(k) K253392

Synergy Disc Instruments by Synergy Spine Solutions, Inc. — Product Code QLQ

K253392 is an FDA 510(k) premarket notification submitted by Synergy Spine Solutions, Inc. for the device "Synergy Disc Instruments". The FDA issued a decision of Substantially Equivalent on March 27, 2026. 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
March 27, 2026
Date Received
September 30, 2025
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

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  • 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