Cleared Traditional

K173030 - Vertera Spine Cohere Cervical Interbody Fusion Device

K173030 is an FDA 510(k) clearance for Vertera Spine Cohere Cervical Interbody..., manufactured by Nu Vasive, Incorporated. The device is a Class 2 Orthopedic device with product code ODP cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K173030 · Nu Vasive, Incorporated · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2017
Decision
54d
Days
Class 2
Risk

K173030 is an FDA 510(k) clearance for the Vertera Spine Cohere Cervical Interbody Fusion Device. Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by Nu Vasive, Incorporated (San Diego, US). The FDA issued a Cleared decision on November 21, 2017 after a review of 54 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Nu Vasive, Incorporated devices

FDA 510(k) Submission Details - K173030

510(k) Number K173030 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2017
Decision Date November 21, 2017
Days to Decision 54 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
68d faster than avg
Panel avg: 122d · This submission: 54d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ODP Device Classification - Class 2, Special Controls

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 Peers - ODP Intervertebral Fusion Device With Bone Graft, Cervical

All 336
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K173030.
NuVasive® Modulus-C Interbody System
K172676 · Nu Vasive, Incorporated · Dec 2017
ACIF
K173148 · Coligne AG · Dec 2017
Altus Spine Cervical Interbody Fusion System
K172253 · Altus Partners, LLC · Nov 2017
SPIRA-C Open Matrix Cervical Interbody
K172446 · Camber Spine Technologies · Nov 2017
CONSTRUX® Mini PTC Spacer System, FORZA® PTC Spacer System, PILLAR® SA PTC Spacer System
K172437 · Orthofix, Inc. · Nov 2017
Sapphire Cervical Implant System
K172674 · Sapphire Medical Group · Nov 2017