510(k) K111166— A-WEDGE ANTERIOR INTERBODY SYSTEM (A-WEDGE A.I.S.)

Substantially Equivalent

Spineworks, LLC

Clearance details

Applicant: Spineworks, LLC
Product code: Code MAX
Advisory panel: Orthopedic
Date received: 2011-04-26
Decision date: 2011-09-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Round Rock, TX, US

Adverse events under product code MAX

product code MAX

Death: 13
Injury: 1,305
Malfunction: 2,885
Total: 4,203

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.