FUSE PLIF CAFE— 510(k) K100945

Substantially Equivalent

Advanced Medical Technologies AG

FDA 510(k) clearance K100945 for FUSE PLIF CAFE, Substantially Equivalent on 2011-02-09. Applicant: Advanced Medical Technologies AG.

Clearance details

Applicant: Advanced Medical Technologies AG
Product code: Code MAX
Advisory panel: Orthopedic
Date received: 2010-04-06
Decision date: 2011-02-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Round Rock, TX, US

Download summary PDF View on FDA.gov ↗

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.