BIOACTION LOW PROFILE SCREW SYSTEM— 510(k) K922788

Substantially Equivalent

Orthopaedic Biosystems

FDA 510(k) clearance K922788 for BIOACTION LOW PROFILE SCREW SYSTEM, Substantially Equivalent on 1993-03-12. Applicant: Orthopaedic Biosystems.

Clearance details

Applicant: Orthopaedic Biosystems
Product code: Code HWC
Advisory panel: Orthopedic
Date received: 1992-06-09
Decision date: 1993-03-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Scottsdale, AZ, US

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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.