Data / Medical devices / United States / Spinal Surgical Strategies, Inc
Spinal Surgical Strategies, Inc: FDA-registered device maker in Incline Village, NV, United States, 1 510(k) clearance
Spinal Surgical Strategies, Inc is registered with the FDA (registration 3011648620) in Incline Village, NV, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated September 14, 2021. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3011648620
- Address
- 999 Driver Way, Incline Village, NV, United States, 89451
- Owner or operator
- Spinal Surgical Strategies, Inc (10049155)
- Roles
- Specification developer
- First device listed
- July 17, 2026
- Registered through
- 2026
- Brand names listed
- KG 2
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | 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 |
|---|---|---|---|---|---|---|
| September 14, 2021 | K211474 | Kleiner KG2 System | MAX | Substantially Equivalent | BAAT Medical Products B.V. | accessdata.fda.gov |
Compare with other makers
Updated September 14, 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.