Spinal USA: FDA filings under this applicant name
FDA lists 24 510(k) clearances under the applicant name “Spinal USA” (first 2006, latest 2013), across 10 product codes in 1 review panel. Median 510(k) review time under this name: 100 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 | 3 | 113 |
| 2013 | 5 | 134 |
| 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 |
|---|---|---|---|
| MNI | Orthosis, Spinal Pedicle Fixation | 8 | 8 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 5 | 5 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 3 | 3 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | 2 | 2 |
| JDK | Prosthesis, Hip, Cement Restrictor | 1 | 1 |
| KWP | Appliance, Fixation, Spinal Interlaminal | 1 | 1 |
| MQP | Spinal Vertebral Body Replacement Device | 1 | 1 |
| MRW | System, Facet Screw Spinal Device | 1 | 1 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 1 | 1 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | 1 | 1 |
Review panels
- Orthopedic (24)
Most recent Spinal USA 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K132029 | VAULT-C INTERVERTEBRAL BODY FUSION DEVICE | OVE | 2013-11-25 | 147 |
| K130863 | FACET SCREW SYSTEM | MRW | 2013-08-09 | 134 |
| K131343 | REFORM PEDICLE SCREW SYSTEM | MNI | 2013-07-24 | 76 |
| K130279 | REFORM PEDICLE SCREW SYSTEM | MNI | 2013-06-20 | 135 |
| K130445 | VAULT ALIF SYSTEM | OVD | 2013-04-25 | 63 |
| K122931 | S-LOK PSS SYSTEM | MNI | 2012-11-20 | 57 |
| K121172 | REFORM PEDICLE SCREW SYSTEM | MNI | 2012-08-08 | 113 |
| K112748 | SLIMPLICITY SOLO ANTERIOR CERVICAL PLATE SYSTEM | KWQ | 2012-07-11 | 294 |
| K112025 | SURE LOK MINI POSTERIOR CERVICAL/UPPER THORACIC SYSTEM | KWP | 2011-09-15 | 62 |
| K103369 | VAULT ALIF SYSTEM | OVD | 2011-04-04 | 138 |
14 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Spinal USA.
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 Simplicity, LLC (16 510(k)s)
- Spinal Specialties, Inc. (8 510(k)s)
- Spinal Innovations, LLC (5 510(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 USA?
FDA lists 24 510(k) clearances under the applicant name “Spinal USA” (first 2006, latest 2013), across 10 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 USA?
The median time from FDA receipt to decision across 510(k)s cleared under the name Spinal USA is 100 days.
Which FDA product codes appear under Spinal USA?
The most frequent FDA product codes under this applicant name are MNI (Orthosis, Spinal Pedicle Fixation, 8); KWQ (Appliance, Fixation, Spinal Intervertebral Body, 5); MAX (Intervertebral Fusion Device With Bone Graft, Lumbar, 3).
Next steps
- See all 24 Spinal USA clearances with predicates and recalls
- Run predicate analysis for product code MNI, Spinal USA'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.