CRYSTALLINE BONE SCREW ENDO-OSSEOUS— 510(k) K834364

Substantially Equivalent

C.B.S. Biotechnics, Inc.

FDA 510(k) clearance K834364 for CRYSTALLINE BONE SCREW ENDO-OSSEOUS, Substantially Equivalent on 1984-03-06. Applicant: C.B.S. Biotechnics, Inc..

Clearance details

Applicant: C.B.S. Biotechnics, Inc.
Product code: Code DZE
Advisory panel: Dental
Date received: 1983-10-27
Decision date: 1984-03-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DZE

product code DZE

Death: 28
Injury: 3,367,041
Malfunction: 19,958
Other: 13
Total: 3,387,040

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.