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FDA 510(k)

Southern Transforaminal Lumbar Interbody Fusion (TLIF)

K-Number: K221182 · 2022-12-08

ApplicantSouthern Medical (Pty) , Ltd.
Decision Date2022-12-08
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Southern Transforaminal Lumbar Interbody Fusion (TLIF) is the device name listed in this FDA 510(k) record. The listed applicant is Southern Medical (Pty) , Ltd.. It received FDA 510(k) clearance on 2022-12-08 under 510(k) number K221182. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Southern Transforaminal Lumbar Interbody Fusion (TLIF)?

Southern Transforaminal Lumbar Interbody Fusion (TLIF) is a medical device that received FDA 510(k) clearance on 2022-12-08. The listed applicant is Southern Medical (Pty) , Ltd.. The 510(k) number is K221182.

When did Southern Transforaminal Lumbar Interbody Fusion (TLIF) receive FDA 510(k) clearance?

Southern Transforaminal Lumbar Interbody Fusion (TLIF) received FDA 510(k) clearance on 2022-12-08, under 510(k) number K221182.

Who is the listed applicant for Southern Transforaminal Lumbar Interbody Fusion (TLIF)?

The FDA 510(k) record lists Southern Medical (Pty) , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Southern Transforaminal Lumbar Interbody Fusion (TLIF)?

The FDA product code for Southern Transforaminal Lumbar Interbody Fusion (TLIF) is MAX.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT048238583Spine Lumbar Fusion Real World Evidence StudyACTIVE_NOT_RECRUITINGNCT05237908Clinical Outcome and Fusion Rate of 3D Printed Interbody Fusion Cages and Titanium Coated PEEK CagesACTIVE_NOT_RECRUITINGNCT05583864Lumbar Fusion With Porous Versus Non-Porous CagesACTIVE_NOT_RECRUITINGNCT07017634Efficacy and Safety of Novosis Putty in Transforaminal Lumbar Interbody Fusion for Patients With Lumbar Degenerative Disc DiseaseRECRUITINGNCT07777718Lumbar Fusion With Nanotube Versus Titanium CageNOT_YET_RECRUITINGNCT05438719MOTUS Total Joint Replacement Investigational Device Exemption StudyACTIVE_NOT_RECRUITING

Related PubMed Literature

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

PMID: 42481192Interventional, multicentre investigation of a novel lumbar total joint replacement: propensity matched study design and protocol.BMJ open (2026)

Other records listing Southern Medical (Pty) , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253373Southern Craniomaxillofacial (CMF) SystemK230608SPICCA Stand-Alone Cervical Fusion CagesK230607SPICCA Cervical Fusion CagesK231145Axis Anterior Cervical Plate SystemK221447Southern Anterior Screw Fixated Cage (SASCA)

Related Devices (Code: MAX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261430TruLift Expandable SystemLife Spine, Inc.K253011Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody System; Meridian Anterior Plate System; Reef L Interbody System; Reef TO/TA System; Regatta Lateral System; Regatta Lateral Plate System; Shoreline ACS Interbody System; Shoreline Threaded TruProfile Plate; Shoreline RT Interbody System; Vu Mesh; WaveForm A Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TA Interbody System; WaveForm TO Interbody SySeaSpine Orthopedics CorporationK253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd.K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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