FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
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
K Number: K201605
·
Decision Jul 15, 2020
Classifications
1
FEI Numbers
418
Registration Numbers
418
Same Product Code
890
Applicant Total
5
Review Days
30
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Basic Information
- Device Name
- 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
- K Number
- K201605
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Eit Emerging Implant Technologies GmbH
- Date Received
- June 15, 2020
- Decision Date
- July 15, 2020
- Product Code
- MAX
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | FDA class 2 | Orthopedic |
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Other Clearances by Eit Emerging Implant Technologies GmbH
| K Number | Device Name | ||
|---|---|---|---|
| K183447 | EIT Cellular Titanium Lumbar Cage - T/PLIF | Feb 4, 2019 | Substantially Equivalent |
| K181644 | EIT Cellular Titanium® Lumbar Cage LLIF | Oct 12, 2018 | Substantially Equivalent |
| K172888 | EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT Cellular Titanium® TLIF Cages, EIT Cellular Titanium® ALIF Cages | Dec 15, 2017 | Substantially Equivalent |
| K170503 | EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular Titanium TLIF Cages, and EIT Cellular Titanium ALIF Cages | Jul 11, 2017 | Substantially Equivalent |