COLLINS POSITIONING DEVICE— 510(k) K864880

Substantially Equivalent

Orthopedic Systems, Inc.

FDA 510(k) clearance K864880 for COLLINS POSITIONING DEVICE, Substantially Equivalent on 1986-12-29. Applicant: Orthopedic Systems, Inc..

Clearance details

Applicant: Orthopedic Systems, Inc.
Product code: Code FWZ
Advisory panel: General, Plastic Surgery
Date received: 1986-12-12
Decision date: 1986-12-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hayward, CA, US

Download summary PDF View on FDA.gov ↗

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.