Spectrum Spine, LLC: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Spectrum Spine, LLC” (first 2013, latest 2026), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 168 days. Since 2017 the median was 222 days, against 107 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 | 2 | 128 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 1 | 478 |
| 2020 | 0 | — |
| 2021 | 1 | 374 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 64 |
| 2025 | 2 | 106 |
| 2026 | 1 | 256 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Spectrum Spine, LLC took a median 222 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 107 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 4 | 4 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 2 | 2 |
| MRW | System, Facet Screw Spinal Device | 1 | 1 |
| NQW | Orthosis, Spine, Plate, Laminoplasty, Metal | 1 | 1 |
Review panels
- Orthopedic (8)
Most recent Spectrum Spine, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252240 | Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage System | ODP | 2026-03-30 | 256 |
| K253377 | Expandable Titanium PLIF/TLIF System | MAX | 2025-10-24 | 24 |
| K243074 | Spectrum Spine Lumbar Cage System | MAX | 2025-04-04 | 189 |
| K240838 | Spectrum Spine Cervical Cage System | ODP | 2024-05-30 | 64 |
| K201024 | Expandable Titanium PLIF/TLIF System | MAX | 2021-04-29 | 374 |
| K173518 | Spectrum Spine Expandable Cages (SSEC) | MAX | 2019-03-07 | 478 |
| K132126 | SPECTRUM SPINE FENESTRATED FACET SCREW SYSTEM | MRW | 2013-10-28 | 110 |
| K122822 | SPECTRUM SPINE LAMINOPLASTY PLATING SYSTEM | NQW | 2013-02-07 | 146 |
Recalls
openFDA lists no recalls under a recalling firm named Spectrum 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.
- Spectrum Designs, Inc. (18 510(k)s)
- Spectrum Medical , Ltd. (15 510(k)s)
- Spectrum X-Ray Corp. (9 510(k)s)
- Spectrum Dynamics Medical, Ltd. (8 510(k)s)
- Spectrum Medical S.R.L. (6 510(k)s)
- Spectrum Vascular (6 510(k)s)
- Spectrum Co. (3 510(k)s)
- Spectrum Diagnostic, Inc. (3 510(k)s)
- Spectrum Dynamics , Ltd. (3 510(k)s)
- Spectrum Medical Technologies, Inc. (3 510(k)s)
- Spectrum Medical, Llp (2 510(k)s)
- Spectrum Antimicrobials, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Spectrum Spine, LLC?
FDA lists 8 510(k) clearances under the applicant name “Spectrum Spine, LLC” (first 2013, latest 2026), across 4 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 Spectrum Spine, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Spectrum Spine, LLC is 168 days. Since 2017: 222 days, versus 107 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Spectrum Spine, LLC?
The most frequent FDA product codes under this applicant name are MAX (Intervertebral Fusion Device With Bone Graft, Lumbar, 4); ODP (Intervertebral Fusion Device With Bone Graft, Cervical, 2); MRW (System, Facet Screw Spinal Device, 1).
Next steps
- See all 8 Spectrum Spine, LLC clearances with predicates and recalls
- Run predicate analysis for product code MAX, Spectrum 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.