Cutting Edge Spine, LLC: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Cutting Edge Spine, LLC” (first 2011, latest 2025), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 102 days. Since 2017 the median was 30 days, against 104 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 | 1 | 154 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 2 | 66 |
| 2019 | 1 | 217 |
| 2020 | 3 | 30 |
| 2021 | 0 | — |
| 2022 | 1 | 176 |
| 2023 | 1 | 23 |
| 2024 | 0 | — |
| 2025 | 1 | 12 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Cutting Edge Spine, LLC took a median 30 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 104 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 6 | 6 |
| OUR | Sacroiliac Joint Fixation | 3 | 3 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 2 | 2 |
Review panels
- Orthopedic (11)
Most recent Cutting Edge Spine, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K250605 | EVOL® ha Hyper C Cervical Interbody Fusion System | ODP | 2025-03-12 | 12 |
| K230689 | T-FIX 3DSI Joint Fusion System | OUR | 2023-04-05 | 23 |
| K214123 | T-FIX® 3DSI Joint Fusion System | OUR | 2022-06-24 | 176 |
| K200991 | EVOL Spinal Interbody System | MAX | 2020-05-13 | 28 |
| K200552 | EVOS Lumbar Interbody System | MAX | 2020-04-02 | 30 |
| K192497 | EVOL ha - D Lateral Interbody Fusion System | MAX | 2020-01-06 | 117 |
| K190025 | EVOL® -SI Joint Fusion System | OUR | 2019-08-12 | 217 |
| K180674 | EVOL® ha-C Cervical Interbody Fusion System | ODP | 2018-06-25 | 102 |
| K180891 | EVOL Spinal Interbody System, EVOS Lumbar Interbody System | MAX | 2018-05-04 | 29 |
| K150321 | EVOS Lumbar Interbody System | MAX | 2015-07-13 | 154 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Cutting Edge 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.
- Cutting Edge Technologies, Inc. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Cutting Edge Spine, LLC?
FDA lists 11 510(k) clearances under the applicant name “Cutting Edge Spine, LLC” (first 2011, latest 2025), across 3 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 Cutting Edge Spine, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cutting Edge Spine, LLC is 102 days. Since 2017: 30 days, versus 104 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Cutting Edge Spine, LLC?
The most frequent FDA product codes under this applicant name are MAX (Intervertebral Fusion Device With Bone Graft, Lumbar, 6); OUR (Sacroiliac Joint Fixation, 3); ODP (Intervertebral Fusion Device With Bone Graft, Cervical, 2).
Next steps
- See all 11 Cutting Edge Spine, LLC clearances with predicates and recalls
- Run predicate analysis for product code MAX, Cutting Edge 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.