510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K033406Substantially Equivalent

Small Bone Fixation System

Hand Innovations, Inc., Miami FL / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K033406 is the FDA 510(k) clearance record for SMALL BONE FIXATION SYSTEM, a class II device, cleared for Hand Innovations, Inc. on under FDA product code HTY (Pin, Fixation, Smooth). FDA records list 17 510(k) clearances for Hand Innovations, Inc., from to . As of , FDA records show no recalls naming K033406.

Clearance record

Decision date
Received
(83 days to decision)
Product code
HTY Pin, Fixation, Smooth
Regulation
21 CFR 888.3040
Device class
Class II
Review panel
Orthopedic
Applicant
Hand Innovations, Inc. 8905 SW 87th Ave., Miami FL
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