A-WEDGE ANTERIOR INTERBODY SYSTEM (A-WEDGE AIS)— 510(k) K121693

Substantially Equivalent

Sapphire Medical Group, Inc.

FDA 510(k) clearance K121693 for A-WEDGE ANTERIOR INTERBODY SYSTEM (A-WEDGE AIS), Substantially Equivalent on 2012-12-27. Applicant: Sapphire Medical Group, Inc..

Clearance details

Applicant: Sapphire Medical Group, Inc.
Product code: Code MAX
Advisory panel: Orthopedic
Date received: 2012-06-07
Decision date: 2012-12-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vero Beach, FL, US

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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.