MODIFICATION TO BONE ANCHOR AND KIT (BAK)— 510(k) K994313

Name: FDA 510(k) clearance K994313
Creator: U.S. Food and Drug Administration
Published: 2000-01-13

Substantially Equivalent

Axya Medical, Inc.

FDA 510(k) clearance K994313 for MODIFICATION TO BONE ANCHOR AND KIT (BAK), Substantially Equivalent on 2000-01-13. Applicant: Axya Medical, Inc.. Device class: 2.

Clearance details

Applicant: Axya Medical, Inc.
Product code: Code GAW
Device class: Class 2
Regulation: 21 CFR 878.5010
Advisory panel: General, Plastic Surgery
Date received: 1999-12-22
Decision date: 2000-01-13
Decision: Substantially Equivalent
Clearance type: Special
Location: Beverly, MA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code GAW

product code GAW

Death: 66
Injury: 1,616
Malfunction: 10,428
Total: 12,110

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.