Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by Spinecraft, LLC. It received FDA 510(k) clearance on 2021-09-30 under approval 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. It is manufactured by Spinecraft, LLC. The 510(k) number is K211935.

When was ORIO-Ti Intervertebral Body Fusion Cage System approved by the FDA?

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

What company makes ORIO-Ti Intervertebral Body Fusion Cage System?

ORIO-Ti Intervertebral Body Fusion Cage System is manufactured by Spinecraft, LLC.

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

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT06011551 HYDRAFIL-D: HYDRogel Augmentation For Intervertebral Lumbar Discs RECRUITING NCT04305925 Focal Laser Ablation of Prostate Cancer COMPLETED NCT07023393 Proprio Spine Measurement Tool WITHDRAWN NCT07485829 Zimmer Biomet-RibFix Titan RECRUITING

Related PubMed Literature

PMID: 41166829 Assessment of intra-operative impact durability of additively manufactured mock lumbar intervertebral body fusion devices. Journal of biomechanics (2026)

Other Devices by Spinecraft, LLC

K181350ASTRA-OCT Spine System K211323ASTRA Spine System K223273ASTRA Spine System K223301ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments System

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.

↑