EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT Cellular Titanium® TLIF Cages, EIT Cellular Titanium® ALIF Cages— 510(k) K172888
Substantially EquivalentEit Emerging Implant Technologies GmbH
FDA 510(k) clearance K172888 for EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT Cellular Titanium® TLIF Cages, EIT Cellular Titanium® ALIF Cages, Substantially Equivalent on 2017-12-15. Applicant: Eit Emerging Implant Technologies GmbH. Device class: 2.
Clearance details
- Applicant
- Eit Emerging Implant Technologies GmbH
- Product code
- Code MAX
- Device class
- Class 2
- Regulation
- 21 CFR 888.3080
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Wurmlingen, DE
Recent devices under product code MAX
view allMore clearances from Eit Emerging Implant Technologies GmbH
view all- K201605 — 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
- K183447 — EIT Cellular Titanium Lumbar Cage - T/PLIF
- K181644 — EIT Cellular Titanium® Lumbar Cage LLIF
- K170503 — EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular Titanium TLIF Cages, and EIT Cellular Titanium ALIF Cages
Adverse events under product code MAX
product code MAX- Death
- 13
- Injury
- 1,305
- Malfunction
- 2,885
- Total
- 4,203
Source: openFDA MAUDE database, through . 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.