Cleared Traditional

K150700 - ACP 1 Anterior Cervical Plating System

K150700 is an FDA 510(k) clearance for ACP 1 Anterior Cervical Plating System, manufactured by Stryker Corporation. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K150700 · Stryker Corporation · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2015
Decision
119d
Days
Class 2
Risk

K150700 is an FDA 510(k) clearance for the ACP 1 Anterior Cervical Plating System. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Stryker Corporation (Allendale, US). The FDA issued a Cleared decision on July 15, 2015 after a review of 119 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 Stryker Corporation devices

FDA 510(k) Submission Details - K150700

510(k) Number K150700 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 2015
Decision Date July 15, 2015
Days to Decision 119 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
3d faster than avg
Panel avg: 122d · This submission: 119d
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 602
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K150700.
Pyrenees Cervical Plate System
K152281 · K2m · Sep 2015
Pyrenees Cervical Plate System
K152015 · K2m, Inc. · Sep 2015
Hyper-C Anterior Cervical Plate System
K150759 · Degen Medical · Jul 2015
Pyrenees Cervical Plate System
K150983 · K2m · 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