DeviceClearance

ANTHREX TITANIUM OPENING WEDGE OSTEOTOMY SYSTEM— 510(k) K032187

Substantially Equivalent

Arthrex, Inc.

FDA 510(k) clearance K032187 for ANTHREX TITANIUM OPENING WEDGE OSTEOTOMY SYSTEM, Substantially Equivalent on 2003-09-22. Applicant: Arthrex, Inc.. Device class: 2.

Clearance details

Applicant
Arthrex, Inc.
Product code
Code HRS
Device class
Class 2
Regulation
21 CFR 888.3030
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Naples, FL, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code HRS

product code HRS
Death
27
Injury
10,340
Malfunction
3,328
Total
13,695

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 K032187

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 K032187.

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