Choice Spine, LLC: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Choice Spine, LLC” (first 2019, latest 2023), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 165 days. Since 2017 the median was 165 days, against 100 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 |
|---|---|---|
| 2019 | 2 | 51 |
| 2020 | 1 | 188 |
| 2021 | 3 | 113 |
| 2022 | 2 | 174 |
| 2023 | 1 | 265 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Choice Spine, LLC took a median 165 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 100 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | 2 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 2 | 2 |
| OLO | Orthopedic Stereotaxic Instrument | 2 | 2 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | 2 | 2 |
| OUR | Sacroiliac Joint Fixation | 1 | 1 |
Review panels
- Orthopedic (9)
Most recent Choice Spine, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K223869 | ChoiceSpine Blackhawk Ti Cervical Spacer System | OVE | 2023-09-14 | 265 |
| K220953 | ChoiceSpine TigerShark M, Modular Interbody System | MAX | 2022-09-13 | 165 |
| K220024 | ChoiceSpine Navigation System | OLO | 2022-07-06 | 182 |
| K211449 | Triton Sacroiliac Joint Fixation System | OUR | 2021-08-31 | 113 |
| K203311 | ChoiceSpine Blackhawk Ti Cervical Spacer System | OVE | 2021-05-10 | 181 |
| K203561 | ChoiceSpine Navigation System | OLO | 2021-01-04 | 28 |
| K201643 | ChoiceSpine Tiger Shark Cervical Spacer System | ODP | 2020-12-22 | 188 |
| K191621 | ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer System Ascendant PC, ChoiceSpine Cervical Interbody Spacer System Ascendant, ChoiceSpine Cervical Spacer System Blackhawk, ChoiceSpine Intervertebral Fusion Device Octane Straight, ChoiceSpine Intervertebral Fusion Device Octane Straight PC, ChoiceSpine VEO Laterial Access & Interbody Fusion System | ODP | 2019-08-15 | 58 |
| K191367 | Harrier-SA Lumbar Interbody System | MAX | 2019-07-05 | 44 |
Recalls
openFDA lists no recalls under a recalling firm named Choice Spine, 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.
- Choice Smart Health Care Co. , Ltd. (3 510(k)s)
- Choice Biotech, Inc. (1 510(k)s)
- Choice Spine, Llp (1 510(k)s)
- Choice Therapeutics (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Choice Spine, LLC?
FDA lists 9 510(k) clearances under the applicant name “Choice Spine, LLC” (first 2019, latest 2023), across 5 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 Choice Spine, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Choice Spine, LLC is 165 days. Since 2017: 165 days, versus 100 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Choice Spine, LLC?
The most frequent FDA product codes under this applicant name are MAX (Intervertebral Fusion Device With Bone Graft, Lumbar, 2); ODP (Intervertebral Fusion Device With Bone Graft, Cervical, 2); OLO (Orthopedic Stereotaxic Instrument, 2).
Next steps
- See all 9 Choice Spine, LLC clearances with predicates and recalls
- Run predicate analysis for product code MAX, Choice Spine, 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.