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FDA 510(k)

ORIO-Ti Intervertebral Body Fusion Cage System

K-Number: K211935 · 2021-09-30

ApplicantSpinecraft, LLC
Decision Date2021-09-30
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ORIO-Ti Intervertebral Body Fusion Cage System is the device name listed in this FDA 510(k) record. The listed applicant is Spinecraft, LLC. It received FDA 510(k) clearance on 2021-09-30 under 510(k) number K211935. 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 ORIO-Ti Intervertebral Body Fusion Cage System?

ORIO-Ti Intervertebral Body Fusion Cage System is a medical device that received FDA 510(k) clearance on 2021-09-30. The listed applicant is Spinecraft, LLC. The 510(k) number is K211935.

When did ORIO-Ti Intervertebral Body Fusion Cage System receive FDA 510(k) clearance?

ORIO-Ti Intervertebral Body Fusion Cage System received FDA 510(k) clearance on 2021-09-30, under 510(k) number K211935.

Who is the listed applicant for ORIO-Ti Intervertebral Body Fusion Cage System?

The FDA 510(k) record lists Spinecraft, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ORIO-Ti Intervertebral Body Fusion Cage System?

The FDA product code for ORIO-Ti Intervertebral Body Fusion Cage System 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.

NCT07739979Radiological Outcome of Bony Fusion After Single Level Anterior Cervical Discectomy and Fusion Using Iliac Crest Graft vs. Polyetheretherketone Cage in Cervical SpondylosisCOMPLETED

Other records listing Spinecraft, LLC 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.

K253260ORIO-3D Cage SystemK260015ANTERIS Thoracolumbar Plate SystemK223301ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments SystemK223273ASTRA Spine SystemK211323ASTRA Spine SystemK181350ASTRA-OCT Spine System

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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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