FDA 510(k)

KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage System

K-Nummer: K233947 · 2024-10-10

Entscheidungsdatum2024-10-10

ProduktcodeMAX

BeratungsausschussOR

EntscheidungSubstantially Equivalent

Produktübersicht

KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage System is the device name listed in this FDA 510(k) record. The listed applicant is Ctl Medical Corporation. It received FDA 510(k) clearance on 2024-10-10 under 510(k) number K233947. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage System?

KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage System is a medical device that received FDA 510(k) clearance on 2024-10-10. The listed applicant is Ctl Medical Corporation. The 510(k) number is K233947.

When did KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage System receive FDA 510(k) clearance?

KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage System received FDA 510(k) clearance on 2024-10-10, under 510(k) number K233947.

Who is the listed applicant for KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage System?

The FDA 510(k) record lists Ctl Medical Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage System?

The FDA product code for KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage System is MAX.

Zugehörige klinische Studien

Zugehörige Einträge werden automatisch anhand von Namen, Produktcodes oder anderen Metadaten abgeglichen. Eine Übereinstimmung begründet kein verifiziertes klinisches, wissenschaftliches, unternehmerisches oder regulatorisches Verhältnis; prüfen Sie die verlinkten offiziellen Quellen.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Weitere Einträge mit Ctl Medical Corporation als Antragsteller

K231715MONDRIAN™ Anterior Lumbar Plate System K231359RODIN™ Expandable Lumbar Cage System K220513NITRO Interbody Fusion Cage System Family K220334MONET Anterior Cervical Plate System K211785CASSATT™ SIJ Fixation System K213641MONDRIAN ALIF Cage with Supplementary Fixation Plate

Alle 14 Geräte anzeigen →

Verwandte Geräte (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 SystemSeaSpine Orthopedics Corporation K253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd.

Offizielle Quelle

In der FDA-Datenbank anzeigen →

Daten aus der FDA Open API. Für die aktuellsten und verbindlichen Informationen konsultieren Sie bitte stets den offiziellen Datensatz.