Electro-Biology, Inc.: FDA filings under this applicant name
FDA lists 28 510(k) clearances under the applicant name “Electro-Biology, Inc.” (first 1983, latest 1999), across 11 product codes in 2 review panels. Median 510(k) review time under this name: 79 days. 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 |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 5 | 5 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 5 | 5 |
| HRX | Arthroscope | 3 | 3 |
| ILO | Pack, Hot Or Cold, Water Circulating | 3 | 3 |
| KWP | Appliance, Fixation, Spinal Interlaminal | 3 | 3 |
| IRP | Massager, Powered Inflatable Tube | 2 | 2 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | 2 | 2 |
| MNI | Orthosis, Spinal Pedicle Fixation | 2 | 2 |
| HWC | Screw, Fixation, Bone | 1 | 1 |
| JEC | Component, Traction, Invasive | 1 | 1 |
Plus 1 more product codes.
Review panels
- Orthopedic (23)
- Physical Medicine (5)
Most recent Electro-Biology, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K992333 | EBI OMEGA 21 SYSTEM | MNI | 1999-10-08 | 87 |
| K992367 | EBI XFIX DYNAFIX SYSTEM HA COATED SCREWS | HWC | 1999-09-23 | 70 |
| K991941 | EBI XFIX DFS RAIL SYSTEM | KTT | 1999-08-19 | 71 |
| K991092 | EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM | KWQ | 1999-04-29 | 28 |
| K990303 | EBI OMEGA 21 SYSTEM | KWP | 1999-04-29 | 87 |
| K990459 | EBI VUECATH ENDOSCOPIC SYSTEN | HRX | 1999-04-23 | 70 |
| K990999 | MODIFICATION OF: EBI SPINELINK SYSTEM | MAI | 1999-04-14 | 20 |
| K984027 | EBI SPINELINK SYSTEM | MNI | 1999-01-19 | 68 |
| K982484 | EBI VUECATH ENDOSCOPIC SPINAL SYSTEM | HRX | 1998-10-08 | 83 |
| K982908 | MODIFICATION TO EBI SPINELINK SYSTEM | KWP | 1998-08-28 | 10 |
18 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Electro-Biology, Inc..
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 Electro-Biology, Inc.?
FDA lists 28 510(k) clearances under the applicant name “Electro-Biology, Inc.” (first 1983, latest 1999), across 11 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Electro-Biology, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Electro-Biology, Inc. is 79 days.
Which FDA product codes appear under Electro-Biology, Inc.?
The most frequent FDA product codes under this applicant name are KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, 5); KWQ (Appliance, Fixation, Spinal Intervertebral Body, 5); HRX (Arthroscope, 3).
Next steps
- See all 28 Electro-Biology, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KTT, Electro-Biology, Inc.'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.