Data / Medical devices / United States / Amplify Surgical
Amplify Surgical: FDA-registered device maker in Foothill Ranch, CA, United States, 3 510(k) clearances
Amplify Surgical is registered with the FDA (registration 3015255331) in Foothill Ranch, CA, United States. It lists 1 device type. The FDA files 3 510(k) clearances under its listings, the newest dated October 18, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015255331
- Address
- 27092 Burbank, Foothill Ranch, CA, United States, 92610
- Owner or operator
- amplify surgical (10059198)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- December 10, 2018
- Registered through
- 2026
- Brand names listed
- DualX
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | 2 | Complaint file establishment, 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 18, 2022 | K222203 | DualXSLIM(R) T/PLIF | MAX | Substantially Equivalent | Amplify Surgical, Inc. | accessdata.fda.gov |
| October 15, 2019 | K192434 | DualX Lumbar Intervertebral Body Fusion Device | MAX | Substantially Equivalent | Amplify Surgical, Inc. | accessdata.fda.gov |
| September 27, 2018 | K181397 | DualX | MAX | Substantially Equivalent | Innovasive, Inc. | accessdata.fda.gov |
Compare with other makers
Updated October 18, 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.