Cleared Special

K150036 - Blue Mountain Cervical Plate System

K150036 is an FDA 510(k) clearance for Blue Mountain Cervical Plate System, manufactured by Spineway. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Special 510(k) pathway after a 118-day FDA review.

K150036 · Spineway · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2015
Decision
118d
Days
Class 2
Risk

K150036 is an FDA 510(k) clearance for the Blue Mountain Cervical Plate System. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Spineway (Ecully, FR). The FDA issued a Cleared decision on May 7, 2015 after a review of 118 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Spineway devices

FDA 510(k) Submission Details - K150036

510(k) Number K150036 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 2015
Decision Date May 07, 2015
Days to Decision 118 days
Submission Type Special
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
4d faster than avg
Panel avg: 122d · This submission: 118d
Pathway characteristics
Modification to existing cleared device.

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

Rich Jansen, Pharm.D.
RICH JANSEN

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 K150036.
uNion Cervical Plate System
K150666 · Ulrich Medical USA · Jun 2015
Captiva Spine SmartLOX Cervical Plate System
K141332 · Captiva Spine · Jun 2015
Azure Anterior Cervical Plate System
K143028 · Orthofix, Inc. · May 2015
Pyrenees Cervical Plate System
K142212 · K2m, Inc. · May 2015
FortiBridge Anterior Cervical Plate System
K143706 · Nanovis Spine, LLC · Apr 2015
LnK Anterior Cervical Plate System
K143279 · L & K Biomed Co., Ltd. · Mar 2015