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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 the device name listed in this FDA 510(k) record. The listed applicant is Ctl Medical Corporation. It received FDA 510(k) clearance on 2023-04-25 under 510(k) 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. The listed applicant is Ctl Medical Corporation. The 510(k) number is K220513.

When did NITRO Interbody Fusion Cage System Family receive FDA 510(k) clearance?

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

Who is the listed applicant for NITRO Interbody Fusion Cage System Family?

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 NITRO Interbody Fusion Cage System Family?

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

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.

NCT04214535Anterior Cervical Disectomy And Fusion Using The Tritanium® C Anterior Cervical Cage For One Or Two-LevelsACTIVE_NOT_RECRUITINGNCT05762055Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative TechnologyENROLLING_BY_INVITATIONNCT07777718Lumbar Fusion With Nanotube Versus Titanium CageNOT_YET_RECRUITING

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 SystemK220334MONET Anterior Cervical Plate SystemK211785CASSATT™ SIJ Fixation SystemK213641MONDRIAN ALIF Cage with Supplementary Fixation Plate

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Related Devices (Code: ODP)

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.

K2530413d Cage CervicalFims Co., Ltd.K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage; Aero® -C Cervical Cage System; AVS® Anchor-C Cervical Cage System; AVS® TL PEEK Spacer; AVS® PL PEEK Spacers; AVS® Navigator PEEK Spacer; AVS® AS PEEK Spacer; Monterey™ AL Interbody System; Aleutian IBF System; Cascadia Interbody System; Chesapeake Stabilization System; Sahara Stabilization System; SANTORINI™ Corpectomy Cage System; MOJAVE Interbody System; VLIFT VERTEBRAL BODY REPLACEMStryker SpineK254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLCK260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.K260850OSTEOMNI SPINAL CAGES SYSTEMOsteomni, Inc.K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, 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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