Atlas Spine, Inc.: FDA filings under this applicant name
FDA lists 19 510(k) clearances under the applicant name “Atlas Spine, Inc.” (first 2007, latest 2026), across 8 product codes in 1 review panel. Median 510(k) review time under this name: 90 days. Since 2017 the median was 87 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 |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 2 | 99 |
| 2018 | 2 | 88 |
| 2019 | 0 | — |
| 2020 | 2 | 120 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 57 |
| 2025 | 2 | 70 |
| 2026 | 1 | 314 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Atlas Spine, Inc. took a median 87 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 | 4 | 4 |
| MQP | Spinal Vertebral Body Replacement Device | 4 | 4 |
| NKB | Thoracolumbosacral Pedicle Screw System | 3 | 3 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 3 | 3 |
| PLR | Spinal Vertebral Body Replacement Device - Cervical | 2 | 2 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 1 | 1 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | 1 | 1 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | 1 | 1 |
Review panels
- Orthopedic (19)
Most recent Atlas Spine, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252822 | Atlas Spine HiRISE Expandable Cervical-p Corpectomy Implant | PLR | 2026-07-15 | 314 |
| K252560 | Atlas Spine HiRISE Expandable Cervical Corpectomy System | PLR | 2025-11-10 | 89 |
| K251969 | Atlas Spine Project X Expandable Posterior Lumbar Interbody System | MAX | 2025-08-15 | 50 |
| K243191 | Atlas Spine Lateral Expandable Interbody System | OVD | 2024-11-26 | 57 |
| K202302 | Atlas Spine Rebar (Ti) Spacer System | ODP | 2020-10-30 | 77 |
| K192570 | Atlas Spine Expandable Cervical Standalone Interbody System | OVE | 2020-02-28 | 163 |
| K182418 | V3 Segmental Plating System | KWQ | 2018-11-29 | 85 |
| K180675 | Atlas Spine Expandable Cervical Interbody System | ODP | 2018-06-13 | 90 |
| K172334 | Ortus Expandable Lumbar Interbody Fusion System | MAX | 2017-10-25 | 84 |
| K162918 | Atlas Spine Expandable Interbody System | MAX | 2017-02-09 | 114 |
9 earlier clearances. See the full list in Caduvo.
Recalls
2 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2013-07-26.
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.
- Atlas Researches , Ltd. (4 510(k)s)
- Atlas Medical (2 510(k)s)
- Atlas Link Technology Co., Ltd. (1 510(k)s)
- Atlas Medical Products, Inc. (1 510(k)s)
- Atlas Surgical Belt Co., Inc. (1 510(k)s)
- Atlas Technology (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Atlas Spine, Inc.?
FDA lists 19 510(k) clearances under the applicant name “Atlas Spine, Inc.” (first 2007, latest 2026), across 8 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 Atlas Spine, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Atlas Spine, Inc. is 90 days. Since 2017: 87 days, versus 91 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Atlas Spine, Inc.?
The most frequent FDA product codes under this applicant name are MAX (Intervertebral Fusion Device With Bone Graft, Lumbar, 4); MQP (Spinal Vertebral Body Replacement Device, 4); NKB (Thoracolumbosacral Pedicle Screw System, 3).
Next steps
- See all 19 Atlas Spine, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MAX, Atlas 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.