Biomet Spine (Aka Ebi, LLC): FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Biomet Spine (Aka Ebi, LLC)” (first 2010, latest 2014), across 8 product codes in 3 review panels. Median 510(k) review time under this name: 118 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 | 4 | 36 |
| 2013 | 2 | 96 |
| 2014 | 4 | 204 |
| 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 |
|---|---|---|---|
| NKB | Thoracolumbosacral Pedicle Screw System | 4 | 4 |
| KWP | Appliance, Fixation, Spinal Interlaminal | 2 | 2 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | 2 |
| FMF | Syringe, Piston | 1 | 1 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 1 | 1 |
| NQW | Orthosis, Spine, Plate, Laminoplasty, Metal | 1 | 1 |
| OSH | Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | 1 | 1 |
| PDQ | Neurosurgical Nerve Locator | 1 | 1 |
Review panels
- Orthopedic (11)
- General Hospital (1)
- Neurology (1)
Most recent Biomet Spine (Aka Ebi, LLC) 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K133518 | MAXAN ANTERIOR CERVICAL PLATE SYSTEM | KWQ | 2014-11-05 | 355 |
| K140710 | BIOMET GRAFT DELIVERY SYRINGES | FMF | 2014-09-04 | 167 |
| K132373 | BIOMET ACCESS SYSTEM | PDQ | 2014-03-27 | 240 |
| K133746 | POLARIS SPINAL SYSTEM | NKB | 2014-03-12 | 93 |
| K131615 | POLARIS SPINAL SYSTEM | OSH | 2013-09-04 | 93 |
| K123549 | POLARIS SPINAL SYSTEM - BALLISTA II PERCUTANEOUS SCREW PLACEMENT SYSTEM | NKB | 2013-02-25 | 98 |
| K123451 | POLARIS SPINAL SYSTEM - BALLISTA II RODS | NKB | 2012-12-03 | 24 |
| K122989 | BIOMET LATERAL SPACER SYSTEM | MAX | 2012-10-24 | 28 |
| K122378 | NEXTGEN ALTIUS OCT SYSTEM | KWP | 2012-09-20 | 45 |
| K113593 | NEXTGEN ALTIUS OCT SYSTEM | KWP | 2012-04-17 | 134 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Biomet Spine (Aka Ebi, LLC).
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Biomet, Inc. (445 510(k)s)
- Biomet Manufacturing Corp (128 510(k)s)
- Biomet Orthopedics, Inc. (41 510(k)s)
- Biomet 3i, Inc. (32 510(k)s)
- Biomet Microfixation (30 510(k)s)
- Biomet Spine (23 510(k)s)
- Biomet Sports Medicine (13 510(k)s)
- Biomet Trauma (7 510(k)s)
- Biomet Micofixation (3 510(k)s)
- Biomet Trauma (Aka Ebi, Lp) (3 510(k)s)
- Biomet UK, Ltd. (3 510(k)s)
- Biomet Manufactuting Corp. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Biomet Spine (Aka Ebi, LLC)?
FDA lists 13 510(k) clearances under the applicant name “Biomet Spine (Aka Ebi, LLC)” (first 2010, latest 2014), across 8 product codes in 3 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 Biomet Spine (Aka Ebi, LLC)?
The median time from FDA receipt to decision across 510(k)s cleared under the name Biomet Spine (Aka Ebi, LLC) is 118 days.
Which FDA product codes appear under Biomet Spine (Aka Ebi, LLC)?
The most frequent FDA product codes under this applicant name are NKB (Thoracolumbosacral Pedicle Screw System, 4); KWP (Appliance, Fixation, Spinal Interlaminal, 2); MAX (Intervertebral Fusion Device With Bone Graft, Lumbar, 2).
Next steps
- See all 13 Biomet Spine (Aka Ebi, LLC) clearances with predicates and recalls
- Run predicate analysis for product code NKB, Biomet Spine (Aka Ebi, LLC)'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.