Choicespine: FDA filings under this applicant name
FDA lists 4 510(k) clearances under the applicant name “Choicespine” (first 2014, latest 2019), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 89 days. Since 2017 the median was 78 days, against 76 days for all cleared 510(k)s in the same product codes. 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 |
|---|---|---|
| 2014 | 1 | 409 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 2 | 89 |
| 2018 | 0 | — |
| 2019 | 1 | 63 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Choicespine took a median 78 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 76 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MQP | Spinal Vertebral Body Replacement Device | 2 | 2 |
| NKB | Thoracolumbosacral Pedicle Screw System | 2 | 2 |
Review panels
- Orthopedic (4)
Most recent Choicespine 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K183588 | Choice Spine Hawkeye Vertebral Body Replacement (VBR) System | MQP | 2019-02-22 | 63 |
| K171686 | Choice Spine Hawkeye Vertebral Body Replacement (VBR) System | MQP | 2017-09-15 | 100 |
| K171456 | Thunderbolt Minimally Invasive and Lancer Open Pedicle Screw Systems | NKB | 2017-08-03 | 78 |
| K132049 | THUNDERBOLT AND LANCER PEDICLE SCREW SYSTEMS | NKB | 2014-08-15 | 409 |
Recalls
openFDA lists no recalls under a recalling firm named Choicespine.
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.
- Choicespine, LP (22 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Choicespine?
FDA lists 4 510(k) clearances under the applicant name “Choicespine” (first 2014, latest 2019), across 2 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 Choicespine?
The median time from FDA receipt to decision across 510(k)s cleared under the name Choicespine is 89 days. Since 2017: 78 days, versus 76 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Choicespine?
The most frequent FDA product codes under this applicant name are MQP (Spinal Vertebral Body Replacement Device, 2); NKB (Thoracolumbosacral Pedicle Screw System, 2).
Next steps
- See all 4 Choicespine clearances with predicates and recalls
- Run predicate analysis for product code MQP, Choicespine'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.