FDA 510(k)

Southern Transforaminal Lumbar Interbody Fusion (TLIF)

Numéro K : K221182 · 2022-12-08

Date de décision2022-12-08

Code produitMAX

Comité consultatifOR

DécisionSubstantially Equivalent

Résumé du dispositif

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.

Questions fréquentes

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.

Essais cliniques associés

Les enregistrements connexes sont mis en correspondance automatiquement à l'aide des noms, codes produits ou autres métadonnées. Une mise en correspondance n'établit pas de relation clinique, scientifique, corporative ou réglementaire vérifiée ; veuillez consulter les sources officielles liées.

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Autres dossiers indiquant Southern Medical (Pty) , Ltd. en tant que demandeur

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Dispositifs connexes (Code : MAX)

K261049SCALA® TLSpineart SA 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 Corporation K253151Système de Cage de Fusion Intervertébral FuleBeijing Fule Science & Technology Development Co., Ltd.

Source officielle

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