Captiva Spine, Inc.: FDA filings under this applicant name
FDA lists 15 510(k) clearances under the applicant name “Captiva Spine, Inc.” (first 2009, latest 2020), across 6 product codes in 1 review panel. Median 510(k) review time under this name: 73 days. Since 2017 the median was 92 days, against 89 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 |
|---|---|---|
| 2012 | 3 | 73 |
| 2013 | 1 | 71 |
| 2014 | 0 | — |
| 2015 | 3 | 255 |
| 2016 | 1 | 57 |
| 2017 | 0 | — |
| 2018 | 3 | 119 |
| 2019 | 0 | — |
| 2020 | 1 | 66 |
| 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 Captiva Spine, Inc. took a median 92 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 89 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 3 | 3 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | 3 | 3 |
| MNI | Orthosis, Spinal Pedicle Fixation | 3 | 3 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 3 | 3 |
| NKB | Thoracolumbosacral Pedicle Screw System | 2 | 2 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 1 | 1 |
Review panels
- Orthopedic (15)
Most recent Captiva Spine, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K193270 | CapLOX II®/TowerLOX® MIS Pedicle Screw System | NKB | 2020-01-31 | 66 |
| K181229 | TirboLOX-C Cervical IBFD | ODP | 2018-09-19 | 133 |
| K180990 | TirboLOX-L Lumbar IBFD | MAX | 2018-08-13 | 119 |
| K180475 | CapLOX II® / TowerLOX® MIS Pedicle Screw System | NKB | 2018-03-19 | 25 |
| K160020 | Captiva Spine and CapLOX II/TowerLOX Pedicle Screw System | MNH | 2016-03-02 | 57 |
| K151116 | CapLOX II/TowerLOX Pedicle Screw System | MNH | 2015-06-26 | 60 |
| K141332 | Captiva Spine SmartLOX Cervical Plate System | KWQ | 2015-06-11 | 386 |
| K142586 | Captiva Spine FuselOX Cervical IBF System | ODP | 2015-05-28 | 255 |
| K131538 | CAPLOX II PEDICLE SCREW SYSTEM/TOWERLOX PEDICLE SCREW SYSTEM | MNH | 2013-08-08 | 71 |
| K122956 | FUSELOX LUMBAR INTERBODY FUSION DEVICE | MAX | 2012-10-25 | 30 |
5 earlier clearances. See the full list in Caduvo.
Recalls
9 product recalls in 5 recall events; 0 initiated in the last five years. Most recent: 2015-02-25.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Captiva Spine, Inc.?
FDA lists 15 510(k) clearances under the applicant name “Captiva Spine, Inc.” (first 2009, latest 2020), across 6 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 Captiva Spine, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Captiva Spine, Inc. is 73 days. Since 2017: 92 days, versus 89 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Captiva Spine, Inc.?
The most frequent FDA product codes under this applicant name are MAX (Intervertebral Fusion Device With Bone Graft, Lumbar, 3); MNH (Orthosis, Spondylolisthesis Spinal Fixation, 3); MNI (Orthosis, Spinal Pedicle Fixation, 3).
Next steps
- See all 15 Captiva Spine, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MAX, Captiva Spine, Inc.'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.