EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular Titanium TLIF Cages, and EIT Cellular Titanium ALIF Cages— 510(k) K170503

Substantially Equivalent

Eit Emerging Implant Technologies GmbH

FDA 510(k) clearance K170503 for EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular Titanium TLIF Cages, and EIT Cellular Titanium ALIF Cages, Substantially Equivalent on 2017-07-11. Applicant: Eit Emerging Implant Technologies GmbH.

Clearance details

Applicant: Eit Emerging Implant Technologies GmbH
Product code: Code MAX
Advisory panel: Orthopedic
Date received: 2017-02-21
Decision date: 2017-07-11
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.