Southern Spine, LLC

FDA Regulatory Profile

Southern Spine, LLC has 0 FDA recalls, 5 inspections, 4 510(k) clearances and 0 compliance actions on record.

Latest inspection
Jan 13, 2020 · NAI
Latest 510(k)
Nov 16, 2021

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Oct 23, 2026Not statedCurrent
510(k) clearances4Oct 4, 2026Not statedCurrent
Inspections5Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Jan 13, 2020Macon, GABiologicsNo Action Indicated (NAI)3006110997
Apr 18, 2018Macon, GABiologicsNo Action Indicated (NAI)3006110997
Apr 29, 2015Macon, GADevicesNo Action Indicated (NAI)3006110997
Sep 24, 2013Macon, GADevicesNo Action Indicated (NAI)3006110997
Mar 24, 2011Macon, GADevicesVoluntary Action Indicated (VAI)3006110997

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

Recent 510(k) Clearances

K-NumberDeviceDate
K211845Deploy Expandable Interbody SystemNov 16, 2021
K130948C-FUSE CERVICAL INTERVERTEBRAL BODY FUSION SYSTEMAug 14, 2013
K123093STABILINK MIS SPINAL FIXATION SYSTEMDec 20, 2012
K063764SOUTHERN SPINE ANTERIOR CERVICAL STABILIZATION SYSTEM, KWIK- FIX CERVICAL SYSTEM, AND KWIK-FIX / TS…May 16, 2007