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FDA 510(k)

Valeo® C+CSC with Lumen Interbody Fusion Device

K-Number: K173453 · 2018-03-05

ApplicantAmedica Corp.
Decision Date2018-03-05
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Valeo® C+CSC with Lumen Interbody Fusion Device is a medical device manufactured by Amedica Corp.. It received FDA 510(k) clearance on 2018-03-05 under approval number K173453. 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 Valeo® C+CSC with Lumen Interbody Fusion Device?

Valeo® C+CSC with Lumen Interbody Fusion Device is a medical device that received FDA 510(k) clearance on 2018-03-05. It is manufactured by Amedica Corp.. The 510(k) number is K173453.

When was Valeo® C+CSC with Lumen Interbody Fusion Device approved by the FDA?

Valeo® C+CSC with Lumen Interbody Fusion Device received FDA 510(k) clearance on 2018-03-05, under approval number K173453.

What company makes Valeo® C+CSC with Lumen Interbody Fusion Device?

Valeo® C+CSC with Lumen Interbody Fusion Device is manufactured by Amedica Corp..

What is the FDA product code for Valeo® C+CSC with Lumen Interbody Fusion Device?

The FDA product code for Valeo® C+CSC with Lumen Interbody Fusion Device is ODP.

Related Clinical Trials

NCT07614529 Hyperangulated vs Standard Videolaryngoscopy vs Direct Laryngoscopy for Double-Lumen Endobronchial Tube Intubation NOT_YET_RECRUITING 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 NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION

Related PubMed Literature

PMID: 41839575 A Perspective for Integrating Real-World Evidence Into the Investigational Device Exemption Study Design for Lumbar Total Joint Replacement. International journal of spine surgery (2026) PMID: 41166829 Assessment of intra-operative impact durability of additively manufactured mock lumbar intervertebral body fusion devices. Journal of biomechanics (2026)

Other Devices by Amedica Corp.

K161405Valeo II Interbody Fusion Device 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.

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