Eisertech, LLC: FDA clearances and approvals
Eisertech, LLC has 8 FDA 510(k) clearances (first 2011, latest 2019), across 5 product codes in 1 review panel. Median 510(k) review time: 108 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 3 | 103 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 2 | 302 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 2 | 87 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Eisertech, LLC's cleared 510(k)s took a median 87 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 88 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 2 | 2 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | 2 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 2 | 2 |
| JDW | Pin, Fixation, Threaded | 1 | 1 |
| NKB | Thoracolumbosacral Pedicle Screw System | 1 | 1 |
Review panels
- Orthopedic (8)
Most recent Eisertech, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K192768 | Temporary Fixation Pins | JDW | 2019-12-26 | 87 |
| K190565 | Cervical Plate | KWQ | 2019-05-31 | 87 |
| K140348 | INTERBODY CAGE | MAX | 2015-04-23 | 436 |
| K142576 | Spinal System | NKB | 2015-02-26 | 167 |
| K122444 | CERVICAL CAGE | ODP | 2012-08-30 | 20 |
| K113170 | CERVICAL PLATE | KWQ | 2012-04-06 | 162 |
| K113478 | PLIF CAGE | MAX | 2012-03-05 | 103 |
| K110915 | CERVICAL CAGE | ODP | 2011-07-22 | 112 |
Recalls
openFDA lists no recalls under a recalling firm named Eisertech, LLC.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Eisertech, LLC have?
Eisertech, LLC has 8 FDA 510(k) clearances (first 2011, latest 2019), across 5 product codes in 1 review panel.
How long does FDA take to clear Eisertech, LLC's 510(k)s?
The median time from FDA receipt to decision across Eisertech, LLC's cleared 510(k)s is 108 days.
What devices does Eisertech, LLC make?
Its most frequent FDA product codes are KWQ (Appliance, Fixation, Spinal Intervertebral Body, 2); MAX (Intervertebral Fusion Device With Bone Graft, Lumbar, 2); ODP (Intervertebral Fusion Device With Bone Graft, Cervical, 2).
Has Eisertech, LLC had device recalls?
openFDA lists no recalls under a recalling firm name matching Eisertech, LLC. Related entities may recall under other names.
Next steps
- See all 8 Eisertech, LLC clearances with predicates and recalls
- Run predicate analysis for product code KWQ, Eisertech, LLC's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.