EIT Cellular Titanium Lumbar Cage - T/PLIF— 510(k) K183447

Substantially Equivalent

Eit Emerging Implant Technologies GmbH

FDA 510(k) clearance K183447 for EIT Cellular Titanium Lumbar Cage - T/PLIF, Substantially Equivalent on 2019-02-04. Applicant: Eit Emerging Implant Technologies GmbH.

Clearance details

Applicant: Eit Emerging Implant Technologies GmbH
Product code: Code MAX
Advisory panel: Orthopedic
Date received: 2018-12-12
Decision date: 2019-02-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wurmlingen, DE

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.