FIXATOR PIN (EXTERNAL)— 510(k) K881511

Substantially Equivalent

Orthopedic Systems, Inc.

FDA 510(k) clearance K881511 for FIXATOR PIN (EXTERNAL), Substantially Equivalent on 1988-06-30. Applicant: Orthopedic Systems, Inc..

Clearance details

Applicant: Orthopedic Systems, Inc.
Product code: Code JDW
Advisory panel: Orthopedic
Date received: 1988-04-11
Decision date: 1988-06-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hayward, CA, 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.