510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K801594Substantially Equivalent

Ace Fischer External Fixation Device

Ace Orthopedic Manufacturing Co., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K801594 is the FDA 510(k) clearance record for ACE FISCHER EXTERNAL FIXATION DEVICE, a class I device, cleared for Ace Orthopedic Manufacturing Co. on under FDA product code HXK (Holder, Needle; Orthopedic). FDA records list 14 510(k) clearances for Ace Orthopedic Manufacturing Co., from to . As of , FDA records show no recalls naming K801594.

Clearance record

Decision date
Received
(57 days to decision)
Product code
HXK Holder, Needle; Orthopedic
Regulation
21 CFR 888.4540
Device class
Class I
Review panel
Orthopedic
Applicant
Ace Orthopedic Manufacturing Co. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code HXK

Trailing 12 months

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

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