EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT Cellular Titanium TLIF Cage, EIT Cellular Titanium LLIF Cage, EIT Cellular Titanium T/PLIF Cage— 510(k) K201605

Substantially Equivalent

Eit Emerging Implant Technologies GmbH

FDA 510(k) clearance K201605 for EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT Cellular Titanium TLIF Cage, EIT Cellular Titanium LLIF Cage, EIT Cellular Titanium T/PLIF Cage, Substantially Equivalent on 2020-07-15. Applicant: Eit Emerging Implant Technologies GmbH.

Clearance details

Applicant: Eit Emerging Implant Technologies GmbH
Product code: Code MAX
Advisory panel: Orthopedic
Date received: 2020-06-15
Decision date: 2020-07-15
Decision: Substantially Equivalent
Clearance type: Special
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.