Cleared Traditional

K173453 - Valeo C+CSC with Lumen Interbody Fusion...

K173453 is the FDA 510(k) clearance for Valeo C+CSC with Lumen Interbody Fusion... by Amedica Corp.. It is a Class 2 Orthopedic device (product code ODP) cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K173453 · Amedica Corp. · Orthopedic device
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Mar 2018
Decision
119d
Days
Class 2
Risk

K173453 is an FDA 510(k) clearance for the Valeo® C+CSC with Lumen Interbody Fusion Device. Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by Amedica Corp. (Slat Lake City, US). The FDA issued a Cleared decision on March 5, 2018 after a review of 119 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3080 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Amedica Corp. devices

Submission Details

510(k) Number K173453 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 2017
Decision Date March 05, 2018
Days to Decision 119 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
3d faster than avg
Panel avg: 122d · This submission: 119d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ODP Intervertebral Fusion Device With Bone Graft, Cervical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize Cervical Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Consultant

Shanna Ryan
Shanna Ryan

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - ODP Intervertebral Fusion Device With Bone Graft, Cervical

All 219
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K173453.
InTice™-C Porous Ti Cervical Interbody System
K173832 · X-Spine Systems, Inc. · May 2018
Cervage
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Alamo® C
K173128 · Alliance Partners, LLC · Mar 2018
ALTA Anterior Cervical Interbody Spacer
K173324 · Astura Medical · Feb 2018
Neurostructures Cavetto® Cervical Cage System
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Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Interbody Fusion Device and Endoskeleton® TCS Interbody Fusion Device
K173535 · Titan Spine, LLC · Feb 2018