SBI LATERAL RHEAD IMPLANT— 510(k) K062898

Substantially Equivalent

Small Bone Innovations, Inc.

FDA 510(k) clearance K062898 for SBI LATERAL RHEAD IMPLANT, Substantially Equivalent on 2006-11-13. Applicant: Small Bone Innovations, Inc..

Clearance details

Applicant: Small Bone Innovations, Inc.
Product code: Code KWI
Advisory panel: Orthopedic
Date received: 2006-09-27
Decision date: 2006-11-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York, NY, US

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Adverse events under product code KWI

product code KWI

Injury: 490
Total: 490

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.