SBI LATERAL RADIO CAPITELLUM— 510(k) K070236

Substantially Equivalent

Small Bone Innovations, Inc.

FDA 510(k) clearance K070236 for SBI LATERAL RADIO CAPITELLUM, Substantially Equivalent on 2007-02-21. Applicant: Small Bone Innovations, Inc..

Clearance details

Applicant: Small Bone Innovations, Inc.
Product code: Code JDB
Advisory panel: Orthopedic
Date received: 2007-01-25
Decision date: 2007-02-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Newyork, NY, US

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Adverse events under product code JDB

product code JDB

Injury: 352
Total: 352

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.