SBI TITANIUM THREADED PIN— 510(k) K071540

Substantially Equivalent

Small Bone Innovations, Inc.

FDA 510(k) clearance K071540 for SBI TITANIUM THREADED PIN, Substantially Equivalent on 2007-08-08. Applicant: Small Bone Innovations, Inc..

Clearance details

Applicant: Small Bone Innovations, Inc.
Product code: Code JDW
Advisory panel: Orthopedic
Date received: 2007-06-05
Decision date: 2007-08-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York, NY, 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.