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FDA 510(k)

NITRO Interbody Fusion Cage System Family

K-Number: K220513 · 2023-04-25

ApplicantCtl Medical Corporation
Decision Date2023-04-25
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

NITRO Interbody Fusion Cage System Family is a medical device manufactured by Ctl Medical Corporation. It received FDA 510(k) clearance on 2023-04-25 under approval number K220513. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NITRO Interbody Fusion Cage System Family?

NITRO Interbody Fusion Cage System Family is a medical device that received FDA 510(k) clearance on 2023-04-25. It is manufactured by Ctl Medical Corporation. The 510(k) number is K220513.

When was NITRO Interbody Fusion Cage System Family approved by the FDA?

NITRO Interbody Fusion Cage System Family received FDA 510(k) clearance on 2023-04-25, under approval number K220513.

What company makes NITRO Interbody Fusion Cage System Family?

NITRO Interbody Fusion Cage System Family is manufactured by Ctl Medical Corporation.

What is the FDA product code for NITRO Interbody Fusion Cage System Family?

The FDA product code for NITRO Interbody Fusion Cage System Family is ODP.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT06462729 LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF) RECRUITING NCT05438719 MOTUS Total Joint Replacement Investigational Device Exemption Study ACTIVE_NOT_RECRUITING NCT04823858 3Spine Lumbar Fusion Real World Evidence Study ACTIVE_NOT_RECRUITING NCT06868979 Optical Imaging in X-linked Disorders. RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION

Related PubMed Literature

PMID: 38273730 Ten-Year Risk of Recall of Novel Spine Devices. Spine (2024)

Other Devices by Ctl Medical Corporation

K162682MATISSE Anterior Cervical Interbody Fusion Cage System K182151MONET Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation Plate K172788MONET™ Anterior Cervical Interbody Fusion Cage System K173185SEURAT™ Universal Pedicle Screw System K172212MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™ K192863MONDRIAN Lumbar Interbody Fusion Cage System

View all 14 devices →

Related Devices (Code: ODP)

K161127The Small PLATEAU (PLATEAU-C) Spacer SystemLife Spine, Inc. K162003IMSE Cervical CageThe Institute of Musculoskeletal Science & Education K160222OIC Cervical PEEK SpacerThe Orthopaedic Implant Company K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc. K162220DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) CageDio Medical Co., Ltd. K161649Virtu C Spinal Implant SystemMet 1 Technologies, LLC

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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