Data / Medical devices / United States / K7 LLC
K7 LLC: FDA-registered device maker in Henderson, NV, United States, 3 510(k) clearances
K7 LLC is registered with the FDA (registration 3010611996) in Henderson, NV, United States. It lists 4 device types. The FDA files 3 510(k) clearances under its listings, the newest dated January 27, 2014. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3010611996
- Address
- 54 Moonrise way, Henderson, NV, United States, 89074
- Owner or operator
- K7 LLC (10045784)
- Roles
- Manufacturer, Specification developer
- First device listed
- December 27, 2013
- Registered through
- 2027
- Brand names listed
- Aversion Pedicle Screw System, K7C, K7P
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Orthosis, Spinal Pedicle Fixation | MNI | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | 2 | 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 27, 2014 | K133103 | AVERSION PEDICLE SCREW SYSTEM | MNI | Substantially Equivalent | K7, LLC | accessdata.fda.gov |
| December 9, 2013 | K133126 | K7 LUMBAR SPACERS | MAX | Substantially Equivalent | K7, LLC | accessdata.fda.gov |
| January 4, 2013 | K123388 | K7C SPACER | ODP | Substantially Equivalent | K7, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Intervertebral Fusion Device With Bone Graft, Cervical
- All makers of Intervertebral Fusion Device With Bone Graft, Lumbar
- All makers of Orthosis, Spinal Pedicle Fixation
- All makers of Orthosis, Spondylolisthesis Spinal Fixation
Updated January 27, 2014. 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.