FDA.report

510(k) K253392

Device
Synergy Disc Instruments
Applicant
Synergy Spine Solutions, Inc.
510(k) number
K253392
Product code
QLQ
Decision
Substantially Equivalent (SESE)
Decision date
2026-03-27
Date received
2025-09-30
Regulation
888.4515
Classification name
Manual Instruments Designed For Use With Total Disc Replacement Devices
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Josh Butters
Address
357 S. Mccaslin Blvd., Suite 120 Louisville CO US 80027 80027

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

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