Data / Medical devices / United States / Spineup Inc
Spineup Inc: FDA-registered device maker in Miami, FL, United States, 1 510(k) clearance
Spineup Inc is registered with the FDA (registration 3021180147) in Miami, FL, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated January 10, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3021180147
- Address
- 2116 Nw 13th Ave Ste 202, Miami, FL, United States, 33142
- Owner or operator
- SpineUp Inc (10085441)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- June 17, 2022
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | 2 | Complaint file establishment, Manufacturer, Specification developer | 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 |
|---|---|---|---|---|---|---|
| January 10, 2022 | K212358 | Romero Cervical Cage | OVE | Substantially Equivalent | Spineup, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Intervertebral Fusion Device With Integrated Fixation, Cervical
- All makers of Intervertebral Fusion Device With Bone Graft, Cervical
Updated January 10, 2022. 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.