510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K943857Substantially Equivalent for Some Indications

External Fixator

Acu Med, Inc., Beaverton OR / Traditional, Substantially Equivalent for Some Indications
FDA source (opens on fda.gov)

K943857 is the FDA 510(k) clearance record for EXTERNAL FIXATOR, a class II device, cleared for Acu Med, Inc. on under FDA product code JEC (Component, Traction, Invasive). FDA records list 48 510(k) clearances for Acu Med, Inc., from to . As of , FDA records show no recalls naming K943857.

Clearance record

Decision date
Received
(172 days to decision)
Product code
JEC Component, Traction, Invasive
Regulation
21 CFR 888.3040
Device class
Class II
Review panel
Orthopedic
Applicant
Acu Med, Inc. 10950 SW 5th St., Beaverton OR
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