Data / Medical devices / United States / Spectrum Spine Inc
Spectrum Spine Inc: FDA-registered device maker in Jasper, GA, United States, 1 510(k) clearance
Spectrum Spine Inc is registered with the FDA (registration 3036496433) in Jasper, GA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated May 30, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3036496433
- Address
- 20 Harmony Ct, Jasper, GA, United States, 30143
- Owner or operator
- Spectrum Spine Inc (10092936)
- Roles
- Manufacturer
- First device listed
- March 7, 2025
- Registered through
- 2026
- Brand names listed
- Spectrum Spine Anterior Cervical Cage
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 30, 2024 | K240838 | Spectrum Spine Cervical Cage System | ODP | Substantially Equivalent | Spectrum Spine, Inc. | accessdata.fda.gov |
Compare with other makers
Updated May 30, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.