510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K143399Substantially Equivalent

Stryker Footed Attachments and Cutting Accessories

Stryker Corp., Portage MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K143399 is the FDA 510(k) clearance record for Stryker Footed Attachments and Cutting Accessories, a class II device, cleared for Stryker Corp. on under FDA product code HBE (Drills, Burrs, Trephines & Accessories (Simple, Powered)). FDA records list 568 510(k) clearances for Stryker Corp., from to . As of , FDA records show one recall naming K143399.

Clearance record

Decision date
Received
(161 days to decision)
Product code
HBE Drills, Burrs, Trephines & Accessories (Simple, Powered)
Regulation
21 CFR 882.4310
Device class
Class II
Review panel
Neurology
Applicant
Stryker Corp. 4100 E Milham Ave., Portage MI
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HBE

Trailing 12 months
2 clearances under product code HBE in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code HBE, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20261
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260