510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K100562Substantially Equivalent

Latitude Elbow Prosthesis

TORNIER Inc., Beverly MA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K100562 is the FDA 510(k) clearance record for LATITUDE ELBOW PROSTHESIS, a class II device, cleared for Tornier, Inc. on under FDA product code JDB (Prosthesis, Elbow, Semi-Constrained, Cemented). FDA records list 140 510(k) clearances for Tornier, Inc., from to . As of , FDA records show 2 recalls naming K100562.

Clearance record

Decision date
Received
(120 days to decision)
Product code
JDB Prosthesis, Elbow, Semi-Constrained, Cemented
Regulation
21 CFR 888.3160
Device class
Class II
Review panel
Orthopedic
Applicant
Tornier, Inc. 100 Cummings Center,, Beverly MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JDB

Trailing 12 months

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

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