Data / Medical devices / United States / Adcura, Inc.
Adcura, Inc.: FDA-registered device maker in Wayzata, MN, United States, 4 510(k) clearances
Adcura, Inc. is registered with the FDA (registration 3013758617) in Wayzata, MN, United States. It lists 2 device types. The FDA files 4 510(k) clearances under its listings, the newest dated October 26, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013758617
- Address
- 18300 Minnetonka Blvd Ste 210, Wayzata, MN, United States, 55391
- Owner or operator
- ADCURA, INC. (10059466)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- January 28, 2019
- Registered through
- 2026
- Brand names listed
- Sagittae, Sagittae®
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | 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 |
|---|---|---|---|---|---|---|
| October 26, 2022 | K223065 | Adcura® Sagittae® Lateral Lumbar Interbody Fusion Devices | MAX | Substantially Equivalent | Adcura, Inc. | accessdata.fda.gov |
| April 30, 2020 | K200816 | SpineEX Sagittae Lateral Lumbar Interbody Fusion Devices | MAX | Substantially Equivalent | Spineex, Inc. | accessdata.fda.gov |
| March 4, 2019 | K190193 | SpineEX Sagittae® Lateral Lumbar Interbody Fusion Devices | MAX | Substantially Equivalent | Spineex, Inc. | accessdata.fda.gov |
| October 5, 2018 | K181531 | SpineEX Sagittae Lateral Lumbar Interbody Fusion Devices | MAX | Substantially Equivalent | Spineex, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Intervertebral Fusion Device With Integrated Fixation, Lumbar
- All makers of Intervertebral Fusion Device With Bone Graft, Lumbar
Updated October 26, 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.