Eit Emerging Implant Technologies GmbH: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Eit Emerging Implant Technologies GmbH” (first 2017, latest 2020), across 1 product code in 1 review panel. Median 510(k) review time under this name: 85 days. Since 2017 the median was 85 days, against 109 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2017 | 2 | 112 |
| 2018 | 1 | 112 |
| 2019 | 1 | 54 |
| 2020 | 1 | 30 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Eit Emerging Implant Technologies GmbH took a median 85 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 109 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 5 | 5 |
Review panels
- Orthopedic (5)
Most recent Eit Emerging Implant Technologies GmbH 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| 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 | 2020-07-15 | 30 |
| K183447 | EIT Cellular Titanium Lumbar Cage - T/PLIF | MAX | 2019-02-04 | 54 |
| K181644 | EIT Cellular Titanium® Lumbar Cage LLIF | MAX | 2018-10-12 | 112 |
| K172888 | EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT Cellular Titanium® TLIF Cages, EIT Cellular Titanium® ALIF Cages | MAX | 2017-12-15 | 85 |
| K170503 | EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular Titanium TLIF Cages, and EIT Cellular Titanium ALIF Cages | MAX | 2017-07-11 | 140 |
Recalls
openFDA lists no recalls under a recalling firm named Eit Emerging Implant Technologies GmbH.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Eit Emerging Implant Technologies GmbH?
FDA lists 5 510(k) clearances under the applicant name “Eit Emerging Implant Technologies GmbH” (first 2017, latest 2020), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Eit Emerging Implant Technologies GmbH?
The median time from FDA receipt to decision across 510(k)s cleared under the name Eit Emerging Implant Technologies GmbH is 85 days. Since 2017: 85 days, versus 109 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Eit Emerging Implant Technologies GmbH?
The most frequent FDA product codes under this applicant name are MAX (Intervertebral Fusion Device With Bone Graft, Lumbar, 5).
Next steps
- See all 5 Eit Emerging Implant Technologies GmbH clearances with predicates and recalls
- Run predicate analysis for product code MAX, Eit Emerging Implant Technologies GmbH's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.