SEGMENTAL DEFECT REPLACEMENT SYSTEM— 510(k) K980609

Substantially Equivalent

Metagen, LLC

FDA 510(k) clearance K980609 for SEGMENTAL DEFECT REPLACEMENT SYSTEM, Substantially Equivalent on 1998-05-18. Applicant: Metagen, LLC.

Clearance details

Applicant: Metagen, LLC
Product code: Code HSB
Advisory panel: Orthopedic
Date received: 1998-02-17
Decision date: 1998-05-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

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Adverse events under product code HSB

product code HSB

Death: 49
Injury: 12,083
Malfunction: 6,561
Other: 1
Total: 18,694

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.