510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K063551Substantially Equivalent

Aequalis Humeral Plate

TORNIER Inc., Saint-Ismier Cedex, FR / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K063551 is the FDA 510(k) clearance record for AEQUALIS HUMERAL PLATE, a class II device, cleared for Tornier on under FDA product code KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component). FDA records list 140 510(k) clearances for Tornier, from to . As of , FDA records show no recalls naming K063551.

Clearance record

Decision date
Received
(28 days to decision)
Product code
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Regulation
21 CFR 888.3030
Device class
Class II
Review panel
Orthopedic
Applicant
Tornier 161 Rue Lavoisier, Saint-Ismier Cedex, FR
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KTT

Trailing 12 months
7 clearances under product code KTT in the twelve months to November 2026, December 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code KTT, trailing twelve months
MonthClearances
December 20252
January 20261
February 20260
March 20261
April 20261
May 20260
June 20261
July 20260
August 20260
September 20260
October 20261
November 20260