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
K920117Substantially Equivalent

Halo Esprit

Itm Corp., Concord CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K920117 is the FDA 510(k) clearance record for HALO ESPRIT, a class II device, cleared for Itm Corp. on under FDA product code JEC (Component, Traction, Invasive). FDA records list one 510(k) clearance for Itm Corp. As of , FDA records show no recalls naming K920117.

Clearance record

Decision date
Received
(267 days to decision)
Product code
JEC Component, Traction, Invasive
Regulation
21 CFR 888.3040
Device class
Class II
Review panel
Orthopedic
Applicant
Itm Corp. 1000 Burnett Ave., Concord CA
510(k) summary
Statement
Third party review
No

Clearances, product code JEC

Trailing 12 months

FDA records hold no clearances under product code JEC in the trailing twelve months.

FDA records show no clearances under product code JEC in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JEC, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260