Data / Medical devices / United States / SpineNet LLC
SpineNet LLC: FDA-registered device maker in Maitland, FL, United States, 2 510(k) clearances
SpineNet LLC is registered with the FDA (registration 3006755626) in Maitland, FL, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated February 5, 2020. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3006755626
- Address
- 901 N. Lake Destiny Rd Suite 101, Maitland, FL, United States, 32751
- Owner or operator
- SpineNet (10022679)
- Roles
- Specification developer
- First device listed
- December 13, 2011
- Registered through
- 2026
- Brand names listed
- SpineNet ACC-AnteriorCervicalCage, SpineNet SSP
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | 2 | Specification developer | accessdata.fda.gov |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | 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 |
|---|---|---|---|---|---|---|
| February 5, 2020 | K200170 | SpineNet SSP System | KWQ | Substantially Equivalent | Spinenet, LLC | accessdata.fda.gov |
| August 25, 2011 | K110733 | DAYTONA ANTERIOR CERVICAL CAGE | ODP | Substantially Equivalent | Spinenet, LLC | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| February 5, 2013 | 65917 | Class II | Terminated | SpineNet Anterior Cervical Cage, Lordotic, Peek (originally submitted as Daytona Anterior Cervical Cage) Product Usage: Is indicated for use in skeletally mature patients with degenerative disc disease of the cervical sp | The recall decision has been made because because it has recently been determined that the instructions for use (IFU) had certain statements that should have been removed prior to initial product marketing. | accessdata.fda.gov |
| February 4, 2013 | 65914 | Class II | Terminated | SpineNet Bone Marrow Aspiration Needle Kit (which is the Ranfac Bone Marrow Aspiration Needle #74150-01M). Use to aspirate bone morrow. | SpineNet was marketing this device to be used with SpineNet ACC device without FDA clearance or approval. | accessdata.fda.gov |
Compare with other makers
- All makers of Appliance, Fixation, Spinal Intervertebral Body
- All makers of Intervertebral Fusion Device With Bone Graft, Cervical
Updated February 5, 2020. 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.