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

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.

Clearance details

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

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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.