DeviceClearance

ORTHOLOC 3DI ANKLE PLATING SYSTEM, ORTHOLOC BONE SCREW— 510(k) K102429

Substantially Equivalent

Wrightmedicaltechnologyinc

FDA 510(k) clearance K102429 for ORTHOLOC 3DI ANKLE PLATING SYSTEM, ORTHOLOC BONE SCREW, Substantially Equivalent on 2010-11-23. Applicant: Wrightmedicaltechnologyinc. Device class: 2.

Clearance details

Applicant
Wrightmedicaltechnologyinc
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
Arlington, TN, 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 K102429

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 K102429.

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