Cleared Traditional

K150759 - Hyper-C Anterior Cervical Plate System

K150759 is an FDA 510(k) clearance for Hyper-C Anterior Cervical Plate System, manufactured by Degen Medical. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K150759 · Degen Medical · Orthopedic device
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Jul 2015
Decision
127d
Days
Class 2
Risk

K150759 is an FDA 510(k) clearance for the Hyper-C Anterior Cervical Plate System. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Degen Medical (Florence, US). The FDA issued a Cleared decision on July 28, 2015 after a review of 127 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - 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 Degen Medical devices

FDA 510(k) Submission Details - K150759

510(k) Number K150759 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 2015
Decision Date July 28, 2015
Days to Decision 127 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
5d slower than avg
Panel avg: 122d · This submission: 127d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWQ Device Classification - Class 2, Special Controls

Product Code KWQ Appliance, Fixation, Spinal Intervertebral Body
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3060
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 - KWQ Appliance, Fixation, Spinal Intervertebral Body

All 471
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K150759.
Cam Lock Plating System
K152282 · Life Spine, Inc. · Nov 2015
ATLANTIS Anterior Cervical Plate System
K152623 · Medtronic Sofamor Danek USA, Inc. · Nov 2015
Pyrenees Cervical Plate System
K152015 · K2m, Inc. · Sep 2015
ACP 1 Anterior Cervical Plating System
K150700 · Stryker Corporation · Jul 2015
Atrax Anterior Cervical Plating System
K150834 · X-Spine Systems, Inc. · Jul 2015
CastleLoc-P Anterior Cervical Plate System
K143271 · L & K Biomed Co., Ltd. · Jul 2015