510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K100926Substantially Equivalent

Arrowhead Fixation Device

Arrow Products, Inc., Hampton GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K100926 is the FDA 510(k) clearance record for ARROWHEAD FIXATION DEVICE, a class II device, cleared for Arrow Products, Inc. on under FDA product code HTY (Pin, Fixation, Smooth). FDA records list one 510(k) clearance for Arrow Products, Inc. As of , FDA records show no recalls naming K100926.

Clearance record

Decision date
Received
(207 days to decision)
Product code
HTY Pin, Fixation, Smooth
Regulation
21 CFR 888.3040
Device class
Class II
Review panel
Orthopedic
Applicant
Arrow Products, Inc. 2593 Lake Erma Dr., Hampton GA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HTY

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