Data / Medical devices / United States / Additive Implants
Additive Implants: FDA-registered device maker in Phoenix, AZ, United States, 3 510(k) clearances
Additive Implants is registered with the FDA (registration 3013961579) in Phoenix, AZ, United States. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated July 16, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013961579
- Address
- 3420 E Shea Blvd Ste 168, Phoenix, AZ, United States, 85028
- Owner or operator
- Additive Implants, Inc. (10052268)
- Roles
- Specification developer
- First device listed
- February 13, 2019
- Registered through
- 2026
- Brand names listed
- SureMAX, SureMAX-SA, SureMAX-X
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | 2 | Specification developer | accessdata.fda.gov |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | 2 | 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 |
|---|---|---|---|---|---|---|
| July 16, 2021 | K211111 | SureMAX-SA Cervical Standalone System | OVE | Substantially Equivalent | Additive Implants, Inc. | accessdata.fda.gov |
| January 3, 2020 | K193359 | SureMAX Family of Cervical Spacers | ODP | Substantially Equivalent | Additive Implants, Inc. | accessdata.fda.gov |
| January 28, 2019 | K182477 | Cervical Spacer | ODP | Substantially Equivalent | Additive Implants, LLC | 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 July 16, 2021. 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.