DeviceClearance

ORTHOFIX MODULSYSTEM— 510(k) K955848

Substantially Equivalent

Orthofix, Inc.

FDA 510(k) clearance K955848 for ORTHOFIX MODULSYSTEM, Substantially Equivalent on 1996-03-20. Applicant: Orthofix, Inc.. Device class: 2.

Clearance details

Applicant
Orthofix, Inc.
Product code
Code JDW
Device class
Class 2
Regulation
21 CFR 888.3040
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Rockville, MD, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code JDW

product code JDW
Injury
717
Total
717

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 K955848

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 K955848.

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