Data / Medical devices / Germany / Eit Emerging Implant Technologies GMBH
Eit Emerging Implant Technologies GMBH: FDA-registered device maker in Wurmlingen Baden-Wurttemberg, Germany, 5 510(k) clearances
Eit Emerging Implant Technologies GMBH is registered with the FDA (registration 3013730328) in Wurmlingen Baden-Wurttemberg, Germany. It lists 4 device types. The FDA files 5 510(k) clearances under its listings, the newest dated July 15, 2020. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3013730328
- Address
- Eisenbahnstrasse 84, Wurmlingen Baden-Wurttemberg, Germany, 78573
- Owner or operator
- EIT Emerging Implant Technologies GmbH (10055063)
- Roles
- Contract manufacturer, Specification developer
- First device listed
- July 17, 2017
- Registered through
- 2027
- Brand names listed
- Conduit, EIT Cellular Titanium ALIF Cages, EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium LLIF Cages, EIT Cellular Titanium PLIF Cages, EIT Cellular Titanium T/PLIF Cages, EIT Cellular Titanium TLIF Cages, EIT Cellular Titanium® ALIF Cages and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | 2 | Contract manufacturer, Specification developer | accessdata.fda.gov |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | 2 | Contract manufacturer, Specification developer | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Specification developer | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 15, 2020 | 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 | MAX | Substantially Equivalent | Eit Emerging Implant Technologies GmbH | accessdata.fda.gov |
| February 4, 2019 | K183447 | EIT Cellular Titanium Lumbar Cage - T/PLIF | MAX | Substantially Equivalent | Eit Emerging Implant Technologies GmbH | accessdata.fda.gov |
| October 12, 2018 | K181644 | EIT Cellular Titanium® Lumbar Cage LLIF | MAX | Substantially Equivalent | Eit Emerging Implant Technologies GmbH | accessdata.fda.gov |
| December 15, 2017 | K172888 | EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT Cellular Titanium® TLIF Cages, EIT Cellular Titanium® ALIF Cages | MAX | Substantially Equivalent | Eit Emerging Implant Technologies GmbH | accessdata.fda.gov |
| July 11, 2017 | K170503 | EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular Titanium TLIF Cages, and EIT Cellular Titanium ALIF Cages | MAX | Substantially Equivalent | Eit Emerging Implant Technologies GmbH | accessdata.fda.gov |
Compare with other makers
- All makers of Intervertebral Fusion Device With Bone Graft, Lumbar
- All makers of Tray, Surgical, Instrument
- All makers of Intervertebral Fusion Device With Bone Graft, Cervical
- All makers of Orthopedic Manual Surgical Instrument
Updated July 15, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.