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
K940429Substantially Equivalent for Some Indications

Ortho Tech Cryologic System

Orthopedic Technology, Inc., Tracy CA / Traditional, Substantially Equivalent for Some Indications
FDA source (opens on fda.gov)

K940429 is the FDA 510(k) clearance record for ORTHO TECH CRYOLOGIC SYSTEM, a class II device, cleared for Orthopedic Technology, Inc. on under FDA product code ILO (Pack, Hot Or Cold, Water Circulating). FDA records list 2 510(k) clearances for Orthopedic Technology, Inc., from to . As of , FDA records show no recalls naming K940429.

Clearance record

Decision date
Received
(162 days to decision)
Product code
ILO Pack, Hot Or Cold, Water Circulating
Regulation
21 CFR 890.5720
Device class
Class II
Review panel
Physical Medicine
Applicant
Orthopedic Technology, Inc. 1905 N. Macarthur Dr., Tracy CA
Third party review
No

Clearances, product code ILO

Trailing 12 months

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

FDA records show no clearances under product code ILO in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code ILO, 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