FDA.report

510(k) K211845

Device
Deploy Expandable Interbody System
Applicant
Southern Spine LLC
510(k) number
K211845
Product code
MAX  
Decision
Substantially Equivalent (SESE)
Decision date
2021-11-16
Date received
2021-06-15
Regulation
888.3080
Classification name
Intervertebral Fusion Device With Bone Graft, Lumbar
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Calder Clay
Address
487 Cherry St. - Third St. Tower Macon GA US 31201 31201

FDA Registration Numbers

Source Documents

510(k) summary PDF

Related GUDID Devices

Primary DIBrandCompanyPublished
00815351022584Deploy™ Expandable Interbody SystemSouthern Spine LLC2022-01-10
00815351022256Deploy™ Expandable Interbody SystemSouthern Spine LLC2022-01-10
00815351022317Deploy™ Expandable Interbody SystemSouthern Spine LLC2022-01-10
00815351022232Deploy™ Expandable Interbody SystemSouthern Spine LLC2022-01-10
00815351022225Deploy™ Expandable Interbody SystemSouthern Spine LLC2022-01-10
00815351022249Deploy™ Expandable Interbody SystemSouthern Spine LLC2022-01-10
00815351022270Deploy™ Expandable Interbody SystemSouthern Spine LLC2022-01-10
00815351022287Deploy™ Expandable Interbody SystemSouthern Spine LLC2022-01-10
00815351022294Deploy™ Expandable Interbody SystemSouthern Spine LLC2022-01-10
00815351022300Deploy™ Expandable Interbody SystemSouthern Spine LLC2022-01-10
00815351022263Deploy™ Expandable Interbody SystemSouthern Spine LLC2022-01-10
00815351022546Deploy™ Expandable Interbody SystemSouthern Spine LLC2022-01-10
00815351022553Deploy™ Expandable Interbody SystemSouthern Spine LLC2022-01-10
00815351022560Deploy™ Expandable Interbody SystemSouthern Spine LLC2022-01-10
00815351022577Deploy™ Expandable Interbody SystemSouthern Spine LLC2022-01-10
00815351022539Deploy™ Expandable Interbody SystemSouthern Spine LLC2022-01-10
00815351022591Deploy™ Expandable Interbody SystemSouthern Spine LLC2022-01-10
00815351022607Deploy™ Expandable Interbody SystemSouthern Spine LLC2022-01-10
00815351022614Deploy™ Expandable Interbody SystemSouthern Spine LLC2022-01-10
00815351022621Deploy™ Expandable Interbody SystemSouthern Spine LLC2022-01-10
00815351022638Deploy™ Expandable Interbody SystemSouthern Spine LLC2022-01-10
00815351022645Deploy™ Expandable Interbody SystemSouthern Spine LLC2022-01-10
00815351022652Deploy™ Expandable Interbody SystemSouthern Spine LLC2022-01-10
00815351022669Deploy™ Expandable Interbody SystemSouthern Spine LLC2022-01-10
00815351022676Deploy™ Expandable Interbody SystemSouthern Spine LLC2022-01-10
00815351022683Deploy™ Expandable Interbody SystemSouthern Spine LLC2022-01-10
00815351022690Deploy™ Expandable Interbody SystemSouthern Spine LLC2022-01-10
00815351022706Deploy™ Expandable Interbody SystemSouthern Spine LLC2022-01-10
00815351022713Deploy™ Expandable Interbody SystemSouthern Spine LLC2022-01-10
00815351022720Deploy™ Expandable Interbody SystemSouthern Spine LLC2022-01-10

Other 510(k) Records For Product Code MAX  

510(k)DeviceApplicantDecision date
K260506Ventana® P/T Lumbar Interbody SystemSpinal Elements, Inc.2026-05-15
K260837VersaLift Expandable SystemLife Spine, Inc.2026-05-12
K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and transforaminal lumbar interbody system; aprevo® cervical interbody system; corra™ cervical plating systemCarlsmed, Inc.2026-05-09
K261067BEE PLIF CageNGMedical GmbH2026-04-30
K254017SWINGO-3D Lumbar Cage SystemImplanet2026-02-26
K253583LUX Expandable Lumbar Interbody SystemXenix Medical2026-02-23
K250773Luna® Ti Interbody Fusion SystemSpinal Elements, Inc.2026-02-04
K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc.2026-01-23
K253266Titanium Interbody SystemSpine Innovation, LLC2026-01-08
K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic)2025-12-19
K252610ZSFab Lumbar Interbody SystemZsfab, Inc.2025-11-25
K252351UniSpace® TPLIF CageCg Medtech Co., Ltd.2025-10-28
K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.2025-10-24
K251479Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar Interbody Fusion Cage (PLIF)); Mobarn 80:20 Lumbar Interbody Fusion System (Transforaminal Lumbar Interbody Fusion Cage (TLIF)); Mobarn 80:20 Lumbar Interbody Fusion System (Direct Lateral Lumbar Interbody Fusion Cage (DLIF)); Mobarn 80:20 Lumbar Interbody Fusion System (Anterior Lumbar Interbody Fusion Cage (ALIF))Mobarn Medical Devices, LLC2025-09-18
K251444Endoskeleton™ Interbody SystemsMedtronic Sofamor Danek USA, Inc.2025-09-04

Legacy Summary

summary

FDA Review

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases