Spinal Innovations, LLC: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Spinal Innovations, LLC” (first 2000, latest 2003), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 90 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 |
|---|---|---|---|
| KWP | Appliance, Fixation, Spinal Interlaminal | 2 | 2 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 2 | 2 |
| MNI | Orthosis, Spinal Pedicle Fixation | 1 | 1 |
Review panels
- Orthopedic (5)
Most recent Spinal Innovations, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K032219 | REVOLUTION SPINAL FIXATION SYSTEM | MNI | 2003-12-19 | 151 |
| K022997 | SPECTRUM CERVICAL SPINAL SYSTEM | KWQ | 2002-12-06 | 88 |
| K013196 | ASCEND SPINAL FIXATION SYSTEM WITH THE SHADOW SPINAL SYSTEM | KWP | 2002-01-30 | 127 |
| K010639 | CONVERGENCE CERVICAL SPINAL SYSTEM | KWQ | 2001-05-30 | 86 |
| K002069 | ASCEND SPINAL FIXATION SYSTEM | KWP | 2000-10-05 | 90 |
Recalls
openFDA lists no recalls under a recalling firm named Spinal Innovations, 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.
- Spinal Elements, Inc. (50 510(k)s)
- Spinal Concepts, Inc. (33 510(k)s)
- Spinal USA (24 510(k)s)
- Spinal Simplicity, LLC (16 510(k)s)
- Spinal Specialties, Inc. (8 510(k)s)
- Spinal Resources, Inc. (4 510(k)s)
- Spinal Edge, LLC (3 510(k)s)
- Spinal Analytics & Geometrical Implant Co, LLC (2 510(k)s)
- Spinal Balance, Inc. (2 510(k)s)
- Spinal Devices, LLC (2 510(k)s)
- Spinal Kinetics, LLC (1 510(k)s)
- Spinal Acoustics, LLC (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Spinal Innovations, LLC?
FDA lists 5 510(k) clearances under the applicant name “Spinal Innovations, LLC” (first 2000, latest 2003), across 3 product codes 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 Spinal Innovations, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Spinal Innovations, LLC is 90 days.
Which FDA product codes appear under Spinal Innovations, LLC?
The most frequent FDA product codes under this applicant name are KWP (Appliance, Fixation, Spinal Interlaminal, 2); KWQ (Appliance, Fixation, Spinal Intervertebral Body, 2); MNI (Orthosis, Spinal Pedicle Fixation, 1).
Next steps
- See all 5 Spinal Innovations, LLC clearances with predicates and recalls
- Run predicate analysis for product code KWP, Spinal Innovations, 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.