510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K911686Substantially Equivalent

Global Total Shoulder, Uncement Humeral Hemi-Shoul

Depuy, Inc., Warsaw IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K911686 is the FDA 510(k) clearance record for GLOBAL TOTAL SHOULDER, UNCEMENT HUMERAL HEMI-SHOUL, a class II device, cleared for Depuy, Inc. on under FDA product code HSD (Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented). FDA records list 220 510(k) clearances for Depuy, Inc., from to . As of , FDA records show no recalls naming K911686.

Clearance record

Decision date
Received
(90 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
Depuy, Inc. P.O. Box 988, Warsaw IN
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