510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K884483Substantially Equivalent

Cruciometer

Mizuho Orthopedic Systems Inc, Hayward CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K884483 is the FDA 510(k) clearance record for CRUCIOMETER, a class I device, cleared for Orthopedic Systems, Inc. on under FDA product code JZE (Spoon, Ear). FDA records list 95 510(k) clearances for MIZUHO ORTHOPEDIC SYSTEMS, INC., from to . As of , FDA records show no recalls naming K884483.

Clearance record

Decision date
Received
(85 days to decision)
Product code
JZE Spoon, Ear
Regulation
21 CFR 874.4420
Device class
Class I
Review panel
Ear, Nose, Throat
Applicant
Orthopedic Systems, Inc. 1897 National Ave., Hayward CA
Third party review
No

Clearances, product code JZE

Trailing 12 months

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

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