510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K943540Substantially Equivalent

Surgical Cutting Burs

Stryker Corp., Portage MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K943540 is the FDA 510(k) clearance record for SURGICAL CUTTING BURS, a class II device, cleared for Stryker Corp. on under FDA product code DZJ (Driver, Wire, And Bone Drill, Manual). FDA records list 568 510(k) clearances for Stryker Corp., from to . As of , FDA records show one recall naming K943540.

Clearance record

Decision date
Received
(131 days to decision)
Product code
DZJ Driver, Wire, And Bone Drill, Manual
Regulation
21 CFR 872.4120
Device class
Class II
Review panel
Dental
Applicant
Stryker Corp. 4100 E Milham Ave., Portage MI
510(k) summary
Summary
Third party review
No

Clearances, product code DZJ

Trailing 12 months
1 clearance under product code DZJ in the twelve months to October 2026, June 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DZJ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260