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FDA 510(k)

MONDRIAN ALIF Cage with Supplementary Fixation Plate

K-Number: K213641 · 2022-09-15

ApplicantCtl Medical Corporation
Decision Date2022-09-15
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MONDRIAN ALIF Cage with Supplementary Fixation Plate 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 2022-09-15 under 510(k) number K213641. 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 MONDRIAN ALIF Cage with Supplementary Fixation Plate?

MONDRIAN ALIF Cage with Supplementary Fixation Plate is a medical device that received FDA 510(k) clearance on 2022-09-15. The listed applicant is Ctl Medical Corporation. The 510(k) number is K213641.

When did MONDRIAN ALIF Cage with Supplementary Fixation Plate receive FDA 510(k) clearance?

MONDRIAN ALIF Cage with Supplementary Fixation Plate received FDA 510(k) clearance on 2022-09-15, under 510(k) number K213641.

Who is the listed applicant for MONDRIAN ALIF Cage with Supplementary Fixation Plate?

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 MONDRIAN ALIF Cage with Supplementary Fixation Plate?

The FDA product code for MONDRIAN ALIF Cage with Supplementary Fixation Plate is MAX.

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Other records listing Ctl Medical Corporation 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.

K233947KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage SystemK231715MONDRIAN™ Anterior Lumbar Plate SystemK231359RODIN™ Expandable Lumbar Cage SystemK220513NITRO Interbody Fusion Cage System FamilyK220334MONET Anterior Cervical Plate SystemK211785CASSATT™ SIJ Fixation System

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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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