510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K173910Substantially Equivalent

Impress SFS System

Cable Fix Medical, LLC, Hernando MS / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K173910 is the FDA 510(k) clearance record for Impress SFS System, a class II device, cleared for Cable Fix Medical, LLC on under FDA product code JDQ (Cerclage, Fixation). FDA records list one 510(k) clearance for Cable Fix Medical, LLC. As of , FDA records show no recalls naming K173910.

Clearance record

Decision date
Received
(266 days to decision)
Product code
JDQ Cerclage, Fixation
Regulation
21 CFR 888.3010
Device class
Class II
Review panel
Orthopedic
Applicant
Cable Fix Medical, LLC 1050 Getwell Rd. S, Hernando MS
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JDQ

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