510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K063081Substantially Equivalent

Aequalis Shoulder System

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

K063081 is the FDA 510(k) clearance record for AEQUALIS SHOULDER SYSTEM, a class II device, cleared for Tornier on under FDA product code HSD (Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented). FDA records list 140 510(k) clearances for Tornier, from to . As of , FDA records show no recalls naming K063081.

Clearance record

Decision date
Received
(30 days to decision)
Product code
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Regulation
21 CFR 888.3690
Device class
Class II
Review panel
Orthopedic
Applicant
Tornier 161 Rue Lavoisier, Monbonnot Saint Martin, FR
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HSD

Trailing 12 months

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

FDA records show no clearances under product code HSD in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HSD, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260