510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K253392Substantially Equivalent

Synergy Disc Instruments

Synergy Spine Solutions Inc, Louisville CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K253392 is the FDA 510(k) clearance record for Synergy Disc Instruments, a class II device, cleared for Synergy Spine Solutions, Inc. on under FDA product code QLQ (Manual Instruments Designed For Use With Total Disc Replacement Devices). FDA's definition for product code QLQ reads: "The devices are intended to manipulate tissue or implant materials for the positioning, alignment, defect creation, placement, or removal of total disc replacement devices". FDA records list one 510(k) clearance for Synergy Spine Solutions, Inc. As of , FDA records show no recalls naming K253392.

Clearance record

Decision date
Received
(178 days to decision)
Product code
QLQ Manual Instruments Designed For Use With Total Disc Replacement Devices
Regulation
21 CFR 888.4515
Device class
Class II
Review panel
Orthopedic
Applicant
Synergy Spine Solutions, Inc. 357 S. Mccaslin Blvd., Suite 120, Louisville CO
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QLQ

Trailing 12 months
2 clearances under product code QLQ in the twelve months to October 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code QLQ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260