EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular Titanium TLIF Cages, and EIT Cellular Titanium ALIF Cages
FDA 510(k) clearance K170503 · decided 2017-07-11
Clearance details
- K-number
- K170503
- Device name
- EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular Titanium TLIF Cages, and EIT Cellular Titanium ALIF Cages
- Applicant
- Eit Emerging Implant Technologies GmbH
- Decision
- Substantially Equivalent
- Date received
- 2017-02-21
- Decision date
- 2017-07-11
- Days to decision
- 140 days
- Clearance type
- Traditional
- Product code
- MAX
- Device class
- 2
- Regulation number
- 888.3080
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Wurmlingen, DE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.