Cleared Traditional

K163602 - Kepler I Cervical Plate System

K163602 is an FDA 510(k) clearance for Kepler I Cervical Plate System, manufactured by Orbbo Surgical, LLC. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K163602 · Orbbo Surgical, LLC · Orthopedic device
Download Printable Device Report (PDF)
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Feb 2017
Decision
57d
Days
Class 2
Risk

K163602 is an FDA 510(k) clearance for the Kepler I Cervical Plate System. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Orbbo Surgical, LLC (Los Angeles, US). The FDA issued a Cleared decision on February 16, 2017 after a review of 57 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Orbbo Surgical, LLC devices

FDA 510(k) Submission Details - K163602

510(k) Number K163602 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 2016
Decision Date February 16, 2017
Days to Decision 57 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
65d faster than avg
Panel avg: 122d · This submission: 57d
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 487
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K163602.
Spider Cervical Plating System
K170224 · X-Spine Systems, Inc. · Jul 2017
Terrace™ Anterior Cervical Plate System
K163104 · Corelink, LLC · Jun 2017
Butrex Lumbar Buttress Plating System
K170530 · X-Spine Systems, Inc. · Mar 2017
LOSPA IS ACP System
K161641 · Corentec Co., Ltd. · Jan 2017
CETRA Anterior Cervical Plate System
K162638 · Orthofix, Inc. · Dec 2016
MEDICREA INTERNATIONAL Anterior Cervical Locking Plate System
K162194 · Medicrea International SA · Dec 2016