510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K092082Substantially Equivalent

Synergy Cannulated Screw System

Synergy Surgical Technologies, LLC, San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K092082 is the FDA 510(k) clearance record for SYNERGY CANNULATED SCREW SYSTEM, a class II device, cleared for Synergy Surgical Technologies, LLC on under FDA product code HWC (Screw, Fixation, Bone). FDA records list one 510(k) clearance for Synergy Surgical Technologies, LLC. As of , FDA records show no recalls naming K092082.

Clearance record

Decision date
Received
(85 days to decision)
Product code
HWC Screw, Fixation, Bone
Regulation
21 CFR 888.3040
Device class
Class II
Review panel
Orthopedic
Applicant
Synergy Surgical Technologies, LLC 11234 El Camino Real, San Diego CA
510(k) summary
Statement
Third party review
No

Clearances, product code HWC

Trailing 12 months
22 clearances under product code HWC in the twelve months to October 2026, May 2026 the highest month at 4.
Show the numbers
Monthly 510(k) clearances under FDA product code HWC, trailing twelve months
MonthClearances
November 20251
December 20251
January 20260
February 20260
March 20262
April 20263
May 20264
June 20262
July 20261
August 20263
September 20264
October 20261