ORTHOFIX EXTERNAL FIXATION SCREW (PIN) WITH HYDROXYAPATITE COATING— 510(k) K974186

Name: FDA 510(k) clearance K974186
Creator: U.S. Food and Drug Administration
Published: 1998-03-18

Substantially Equivalent

Orthofix Srl

FDA 510(k) clearance K974186 for ORTHOFIX EXTERNAL FIXATION SCREW (PIN) WITH HYDROXYAPATITE COATING, Substantially Equivalent on 1998-03-18. Applicant: Orthofix Srl. Device class: 2.

Clearance details

Applicant: Orthofix Srl
Product code: Code JDW
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 1997-11-07
Decision date: 1998-03-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockville, MD, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code JDW

product code JDW

Injury: 717
Total: 717

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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