510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K834515Substantially Equivalent

Fixation Staple Kit - Dlide Hammer

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

K834515 is the FDA 510(k) clearance record for FIXATION STAPLE KIT - DLIDE HAMMER, a class I device, cleared for Stryker Corp. on under FDA product code HXJ (Staple Driver). FDA records list 568 510(k) clearances for Stryker Corp., from to . As of , FDA records show no recalls naming K834515.

Clearance record

Decision date
Received
(124 days to decision)
Product code
HXJ Staple Driver
Regulation
21 CFR 888.4540
Device class
Class I
Review panel
Orthopedic
Applicant
Stryker Corp. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code HXJ

Trailing 12 months

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

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