Data / Medical devices / United States / Southern Spine, LLC
Southern Spine, LLC: FDA-registered device maker in Macon, GA, United States, 5 510(k) clearances
Southern Spine, LLC is registered with the FDA (registration 3006110997) in Macon, GA, United States. It lists 4 device types. The FDA files 5 510(k) clearances under its listings, the newest dated November 16, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3006110997
- Address
- 487 Cherry Street Third Street Tower, Macon, GA, United States, 31201
- Owner or operator
- SOUTHERN SPINE, LLC (9094669)
- Roles
- Specification developer
- First device listed
- November 16, 2006
- Registered through
- 2026
- Brand names listed
- C-Fuse Cervical Intervertebral Body Fusion System, Deploy Expandable Interbody System, Kwik-Fix Cervical System, Kwik-Fix/TS Cervical System, SOUTHERN SPINE ANTERIOR CE, SSACSS, StabiLink MIS Spinal Fixation System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Appliance, Fixation, Spinal Interlaminal | KWP | 2 | Specification developer | accessdata.fda.gov |
| 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 |
| 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 |
|---|---|---|---|---|---|---|
| November 16, 2021 | K211845 | Deploy Expandable Interbody System | MAX | Substantially Equivalent | Southern Spine, LLC | accessdata.fda.gov |
| August 14, 2013 | K130948 | C-FUSE CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM | ODP | Substantially Equivalent | Southern Spine, LLC | accessdata.fda.gov |
| December 20, 2012 | K123093 | STABILINK MIS SPINAL FIXATION SYSTEM | KWP | Substantially Equivalent | Southern Spine, LLC | accessdata.fda.gov |
| May 16, 2007 | K063764 | SOUTHERN SPINE ANTERIOR CERVICAL STABILIZATION SYSTEM, KWIK- FIX CERVICAL SYSTEM, AND KWIK-FIX / TS CERVICAL SYSTEM | KWQ | Substantially Equivalent | Southern Spine, LLC | accessdata.fda.gov |
| June 27, 2003 | K021979 | SMISSON STABILIZATION SYSTEM | KWQ | Substantially Equivalent | Smisson-Cartledge | accessdata.fda.gov |
Compare with other makers
- All makers of Appliance, Fixation, Spinal Intervertebral Body
- All makers of Appliance, Fixation, Spinal Interlaminal
- All makers of Intervertebral Fusion Device With Bone Graft, Lumbar
- All makers of Intervertebral Fusion Device With Bone Graft, Cervical
Updated November 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.