DeviceClearance

LATITUDE ELBOW PROSTHESIS— 510(k) K100562

Substantially Equivalent

Tornier, Inc.

FDA 510(k) clearance K100562 for LATITUDE ELBOW PROSTHESIS, Substantially Equivalent on 2010-06-29. Applicant: Tornier, Inc.. Device class: 2.

Clearance details

Applicant
Tornier, Inc.
Product code
Code JDB
Device class
Class 2
Regulation
21 CFR 888.3160
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Beverly, MA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code JDB

product code JDB
Injury
352
Total
352

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K100562

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K100562.

Data sourced from openFDA. This site is unofficial and independent of the FDA.