CLARK SOCKET, SIDE RAIL SOCKET, SIDE RAIL SECTION— 510(k) K870101

Substantially Equivalent

Orthopedic Systems, Inc.

FDA 510(k) clearance K870101 for CLARK SOCKET, SIDE RAIL SOCKET, SIDE RAIL SECTION, Substantially Equivalent on 1987-02-06. Applicant: Orthopedic Systems, Inc..

Clearance details

Applicant: Orthopedic Systems, Inc.
Product code: Code FWZ
Advisory panel: General, Plastic Surgery
Date received: 1987-01-09
Decision date: 1987-02-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hayward, CA, US

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Adverse events under product code FWZ

product code FWZ

Malfunction: 932
Other: 1
Total: 933

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.