Cleared Traditional

K143685 - Hedgehog Cervical Interbody Fusion Device

K143685 is an FDA 510(k) clearance for Hedgehog Cervical Interbody Fusion Device, manufactured by Vertera, Inc.. The device is a Class 2 Orthopedic device with product code ODP cleared through the Traditional 510(k) pathway after a 273-day FDA review.

K143685 · Vertera, Inc. · Orthopedic device
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Sep 2015
Decision
273d
Days
Class 2
Risk

K143685 is an FDA 510(k) clearance for the Hedgehog Cervical Interbody Fusion Device. Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by Vertera, Inc. (Atlanta, US). The FDA issued a Cleared decision on September 23, 2015 after a review of 273 days - an extended review 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: 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 Vertera, Inc. devices

FDA 510(k) Submission Details - K143685

510(k) Number K143685 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 24, 2014
Decision Date September 23, 2015
Days to Decision 273 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
151d slower than avg
Panel avg: 122d · This submission: 273d
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 251
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K143685.
PERIMETER C (Titanium) Spinal System
K153438 · Medtronic Sofamor Danek USA, Inc. · Mar 2016
CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System, PEEK PREVAIL Cervical Interbody Device
K153373 · Medtronic Sofamor Danek · Jan 2016
AERO -C Cervical Cage System
K152532 · Stryker Spine · Dec 2015
CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer System
K150619 · Orthofix, Inc. · Sep 2015
Genesys Spine Apache Cervical Interbody Fusion System
K150812 · Genesys Spine · Sep 2015
Foundation Interbody Devices
K150847 · Corelink, LLC · Aug 2015