Cleared Traditional

K142345 - Talos-C(HA) Cervical Intervertebral Bod...

K142345 is an FDA 510(k) clearance for Talos-C(HA) Cervical Intervertebral Bod..., manufactured by Meditech Spine, LLC. The device is a Class 2 Orthopedic device with product code ODP cleared through the Traditional 510(k) pathway after a 184-day FDA review.

K142345 · Meditech Spine, LLC · Orthopedic device
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Feb 2015
Decision
184d
Days
Class 2
Risk

K142345 is an FDA 510(k) clearance for the Talos-C(HA) Cervical Intervertebral Body Fusion Devices. Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by Meditech Spine, LLC (Atlanta, US). The FDA issued a Cleared decision on February 22, 2015 after a review of 184 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 Meditech Spine, LLC devices

FDA 510(k) Submission Details - K142345

510(k) Number K142345 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 2014
Decision Date February 22, 2015
Days to Decision 184 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
62d slower than avg
Panel avg: 122d · This submission: 184d
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 246
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K142345.
Mecta-C TiPEEK
K142744 · Medacta International · May 2015
LnK Cervical Interbody Fusion Cage System
K143360 · L & K Biomed Co., Ltd. · Apr 2015
Coalition AGX Plate and Coalition AGX Spacer
K142218 · Globus Medical, Inc. · Mar 2015
CONSTRUX MINI PEEK
K142152 · Orthofix, Inc. · Jan 2015
ARENA-C TIFUSE CERVICAL INTERVERTEBRAL BODY FUSION DEVICE
K141333 · Spinefrontier, Inc. · Nov 2014
AVS AS PEEK Spacer
K142251 · Stryker Corporation · Nov 2014