Ebi, L.P.: FDA filings under this applicant name
FDA lists 95 510(k) clearances under the applicant name “Ebi, L.P.” (first 1997, latest 2010), plus 1 PMA decision, across 19 product codes in 4 review panels. Median 510(k) review time under this name: 30 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 | 35 | 35 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 10 | 10 |
| NKB | Thoracolumbosacral Pedicle Screw System | 10 | 10 |
| HRS | Plate, Fixation, Bone | 6 | 6 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | 6 | 6 |
| MQP | Spinal Vertebral Body Replacement Device | 6 | 6 |
| MNI | Orthosis, Spinal Pedicle Fixation | 4 | 4 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 3 | 3 |
| BSO | Catheter, Conduction, Anesthetic | 2 | 2 |
| HAW | Neurological Stereotaxic Instrument | 2 | 2 |
Plus 9 more product codes.
Review panels
- Orthopedic (91)
- Anesthesiology (2)
- Neurology (2)
- Physical Medicine (1)
Most recent Ebi, L.P. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K100438 | POLARIS SPINAL SYSTEM, POLARIS/SYNERGY STRUCTURE ANTERIOR FIXATION SYSTEM | NKB | 2010-06-23 | 126 |
| K100220 | POLARIS SPINAL SYSTEM | NKB | 2010-05-17 | 111 |
| K093880 | PEANUT GROWTH CONTROL PLATING SYSTEM | HRS | 2010-04-16 | 119 |
| K092574 | ESL SPINAL SYSTEM | MAX | 2010-02-04 | 167 |
| K093057 | BIOMET VISION FOOTRING SYSTEM | KTT | 2009-12-01 | 62 |
| K092336 | C-THRU SPINAL SYSTEM | MQP | 2009-10-15 | 72 |
| K091381 | IBEX SPINAL SYSTEM | MAX | 2009-08-07 | 88 |
| K090203 | 5.5 HELICAL FLANGE SPINAL SYSTEM, POLARIS COMPONENTS | NKB | 2009-07-30 | 184 |
| K090523 | POLARIS SPINAL SYSTEM | NKB | 2009-07-01 | 125 |
| K082406 | EXPANDABLE PEEK-OPTIMA IMPLANT | MAX | 2009-01-14 | 146 |
85 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P820008 | PMA | SCOLITRON(TM) STIMULATOR | 1983-01-06 |
Recalls
47 product recalls in 8 recall events; 0 initiated in the last five years. Most recent: 2009-04-02.
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 Ebi, L.P.?
FDA lists 95 510(k) clearances under the applicant name “Ebi, L.P.” (first 1997, latest 2010), plus 1 PMA decision, across 19 product codes in 4 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 Ebi, L.P.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ebi, L.P. is 30 days.
Which FDA product codes appear under Ebi, L.P.?
The most frequent FDA product codes under this applicant name are KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, 35); KWQ (Appliance, Fixation, Spinal Intervertebral Body, 10); NKB (Thoracolumbosacral Pedicle Screw System, 10).
Next steps
- See all 95 Ebi, L.P. clearances with predicates and recalls
- Run predicate analysis for product code KTT, Ebi, L.P.'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.