Camber Spine Technologies: FDA filings under this applicant name
FDA lists 23 510(k) clearances under the applicant name “Camber Spine Technologies” (first 2013, latest 2024), across 9 product codes in 1 review panel. Median 510(k) review time under this name: 139 days. Since 2017 the median was 139 days, against 91 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 |
|---|---|---|
| 2013 | 1 | 261 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 127 |
| 2017 | 5 | 139 |
| 2018 | 4 | 132 |
| 2019 | 2 | 169 |
| 2020 | 1 | 163 |
| 2021 | 1 | 106 |
| 2022 | 2 | 378 |
| 2023 | 3 | 99 |
| 2024 | 3 | 203 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Camber Spine Technologies took a median 139 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 91 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 8 | 8 |
| OUR | Sacroiliac Joint Fixation | 3 | 3 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | 3 | 3 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 2 | 2 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 2 | 2 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | 2 | 2 |
| MQP | Spinal Vertebral Body Replacement Device | 1 | 1 |
| NKB | Thoracolumbosacral Pedicle Screw System | 1 | 1 |
| OLO | Orthopedic Stereotaxic Instrument | 1 | 1 |
Review panels
- Orthopedic (23)
Most recent Camber Spine Technologies 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K234077 | SPIRA® Anterior Lumbar Spacers | MAX | 2024-07-12 | 203 |
| K232256 | Alcantara Thoracolumbar Plate System | KWQ | 2024-04-16 | 263 |
| K233972 | Camber Sacroiliac (SI) Fixation System | OUR | 2024-02-27 | 74 |
| K230942 | SPIRA® Posterior Lumbar Spacers | MAX | 2023-07-11 | 99 |
| K221324 | ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF) | OVD | 2023-03-30 | 328 |
| K223837 | SPIRA®-C Integrated Fixation System | OVE | 2023-03-22 | 90 |
| K203503 | Camber Sacroiliac (SI) Fixation System | OUR | 2022-09-02 | 641 |
| K220038 | Camber Spine Navigation System | OLO | 2022-04-29 | 114 |
| K210595 | SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar Spacers | MAX | 2021-06-15 | 106 |
| K193153 | SPIRA-C Integrated Fixation System | OVE | 2020-04-24 | 163 |
13 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Camber Spine Technologies.
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.
- Camber Spine (4 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Camber Spine Technologies?
FDA lists 23 510(k) clearances under the applicant name “Camber Spine Technologies” (first 2013, latest 2024), across 9 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 Camber Spine Technologies?
The median time from FDA receipt to decision across 510(k)s cleared under the name Camber Spine Technologies is 139 days. Since 2017: 139 days, versus 91 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Camber Spine Technologies?
The most frequent FDA product codes under this applicant name are MAX (Intervertebral Fusion Device With Bone Graft, Lumbar, 8); OUR (Sacroiliac Joint Fixation, 3); OVD (Intervertebral Fusion Device With Integrated Fixation, Lumbar, 3).
Next steps
- See all 23 Camber Spine Technologies clearances with predicates and recalls
- Run predicate analysis for product code MAX, Camber Spine Technologies'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.