BTI LARGE (7.0MM) CANNULATED TRANSFIXING SCREWS— 510(k) K974756

Substantially Equivalent for Some Indications

Biodynamic Technologies, Inc.

FDA 510(k) clearance K974756 for BTI LARGE (7.0MM) CANNULATED TRANSFIXING SCREWS, Substantially Equivalent for Some Indications on 1998-03-12. Applicant: Biodynamic Technologies, Inc..

Clearance details

Applicant: Biodynamic Technologies, Inc.
Product code: Code HWC
Advisory panel: Orthopedic
Date received: 1997-12-19
Decision date: 1998-03-12
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Deerfield Beach, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HWC

product code HWC

Death: 20
Injury: 15,910
Malfunction: 8,192
Other: 1
Total: 24,123

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.