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 EquivalentEit 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. 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
- Special
- Location
- Wurmlingen, DE
Recent devices under product code MAX
view allMore clearances from Eit Emerging Implant Technologies GmbH
view all- K183447 — EIT Cellular Titanium Lumbar Cage - T/PLIF
- K181644 — EIT Cellular Titanium® Lumbar Cage LLIF
- K172888 — EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT Cellular Titanium® TLIF Cages, EIT Cellular Titanium® ALIF Cages
- 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.