FDA.reportPublic FDA data

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

Applicant Contact#

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

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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510(k), Device, Applicant table
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