SPINOCAN(R) CONTINUOUS SPINAL TRAY— 510(k) K895192

Substantially Equivalent

Burron Medical, Inc.

FDA 510(k) clearance K895192 for SPINOCAN(R) CONTINUOUS SPINAL TRAY, Substantially Equivalent on 1989-09-18. Applicant: Burron Medical, Inc..

Clearance details

Applicant: Burron Medical, Inc.
Product code: Code CAZ
Advisory panel: Anesthesiology
Date received: 1989-08-11
Decision date: 1989-09-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bethlehem, PA, US

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Adverse events under product code CAZ

product code CAZ

Injury: 145
Malfunction: 942
Other: 1
Total: 1,088

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.