Spine Next America: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Spine Next America” (first 2004, latest 2004), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 76 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 |
|---|---|---|---|
| MNI | Orthosis, Spinal Pedicle Fixation | 2 | 2 |
| MQP | Spinal Vertebral Body Replacement Device | 2 | 2 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 1 | 1 |
Review panels
- Orthopedic (5)
Most recent Spine Next America 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K042714 | FIDJI-VERTEBRAL BODY REPLACEMENT TYPE 1, 2, 3 AND 4 | MQP | 2004-12-29 | 96 |
| K042713 | FIDJI-VERTEBRAL BODY REPLACEMENT TYPE 5 | MQP | 2004-12-29 | 90 |
| K033965 | SHIRAZ-ANTERIOR SYSTEM | KWQ | 2004-03-04 | 73 |
| K033947 | SHIRAZ POSTERIOR SYSTEM | MNI | 2004-03-04 | 76 |
| K033772 | SHIRAZ-JAVA SPINAL FIXATION SYSTEM | MNI | 2004-01-27 | 55 |
Recalls
openFDA lists no recalls under a recalling firm named Spine Next America.
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.
- Spine Wave, Inc. (59 510(k)s)
- Spine Vision, Inc. (12 510(k)s)
- Spine Smith Partners L.P. (9 510(k)s)
- Spine View, Inc. (9 510(k)s)
- Spine Next SA (3 510(k)s)
- Spine Smith Holdings, LLC (3 510(k)s)
- Spine Innovation, LLC (2 510(k)s)
- Spine Works (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Spine Next America?
FDA lists 5 510(k) clearances under the applicant name “Spine Next America” (first 2004, latest 2004), 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 Spine Next America?
The median time from FDA receipt to decision across 510(k)s cleared under the name Spine Next America is 76 days.
Which FDA product codes appear under Spine Next America?
The most frequent FDA product codes under this applicant name are MNI (Orthosis, Spinal Pedicle Fixation, 2); MQP (Spinal Vertebral Body Replacement Device, 2); KWQ (Appliance, Fixation, Spinal Intervertebral Body, 1).
Next steps
- See all 5 Spine Next America clearances with predicates and recalls
- Run predicate analysis for product code MNI, Spine Next America'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.