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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Optimized for regulatory review, auditing and printing
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
Combination Product No
PCCP Authorized No
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 Consultant

Secure BioMed Evaluations
Linda Braddon

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 - KWQ Appliance, Fixation, Spinal Intervertebral Body

All 640
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K150759.
Renovis Anterior Cervical Plate System
K152193 · Renovis Surgical Technologies, Inc. · Sep 2015
Pyrenees Cervical Plate System
K152281 · K2m · Sep 2015
Pyrenees Cervical Plate System
K152015 · K2m, Inc. · Sep 2015
ACP 1 Anterior Cervical Plating System
K150700 · Stryker Corporation · Jul 2015
Pyrenees Cervical Plate System
K150983 · K2m · Jul 2015
Atrax Anterior Cervical Plating System
K150834 · X-Spine Systems, Inc. · Jul 2015