SOUTHERN SPINE, LLC

FDA Device Registration & Listing · Macon, GA, US · Registration 3006110997

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3006110997
FEI Number
3006110997
Entity Name
SOUTHERN SPINE, LLC
City/State/Country
Macon, GA, US
Establishment Address
487 Cherry Street, Third Street Tower, Macon, GA 31201, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
SOUTHERN SPINE, LLC (Owner Number: 9094669)
Owner / Operator Contact Address
487 Cherry Street, Third Street Tower, Macon, GA 31201, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K021979
PMA Number
N/A

All Registered Proprietary Names

C-Fuse Cervical Intervertebral Body Fusion System StabiLink MIS Spinal Fixation System Deploy Expandable Interbody System SSACSS Kwik-Fix Cervical System SOUTHERN SPINE ANTERIOR CE

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2013-08-21
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-08-21
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2021-11-29
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2006-11-16

Official Correspondent

DONNA STEVENSON

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

SOUTHERN SPINE, LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K142269 Reliance Medical Systems, LLC Reliance Cervical IBF System 2015-06-09
K122085 Omni Surgical, LP Dba Spine360 STINGRAY CERVICAL CAGE 2012-10-17
K120275 Synthes (Usa), LLC SYNTHES ACIS/VERTEBRAL SPACER CR 2012-05-25
K963639 Acromed Corp. ACROMED PEDICLE SCREW 1996-11-14
K223430 Life Spine, Inc. ProLift Micro Expandable Spacer System 2023-05-04

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0026-2011 Zimmer Inc. 2
SpeedLink 5.5 Transverse Connector Short 39.5-44mm, non-sterile, 1302-55S
Z-0027-2011 Zimmer Inc. 2
SpeedLink 5.5 Transverse Connector Medium 43-51mm, non-sterile, 1302-55M
Z-0028-2011 Zimmer Inc. 2
SpeedLink 5.5 Transverse Connector Long 50-65mm, non-sterile, 1302-55L
Z-0029-2011 Zimmer Inc. 2
SpeedLink 5.5 Transverse Connector X-Long 60-75mm, non-sterile, 1302-55XL
Z-0030-2011 Zimmer Inc. 2
SpeedLink 6.0 Transverse Connector Short 39.5-44mm, non-sterile, 1304-60S

Similar Registrations

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3027726367 HAPPE SPINE Grand Rapids, MI, US
3027201862 XCIX DESIGN, LLC Richmond, UT, US
3017936978 CARLSMED, INC. Carlsbad, CA, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006110997. Last updated year: 2026. Please use registration number 3006110997 when referencing this establishment in official correspondence.
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