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) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
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 Consultant

Novus Management Group, LLC
Tamala J. Wampler

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 657
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K163602.
Ocata Anterior Cervical System
K170342 · Kalitec Direct, LLC · May 2017
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K170530 · X-Spine Systems, Inc. · Mar 2017
Z-Span Plate System
K162824 · Zavation, LLC · Feb 2017
Altus Spine Cervical Plate System
K163061 · Altus Partners, LLC · Feb 2017
LOSPA IS ACP System
K161641 · Corentec Co., Ltd. · Jan 2017
Sphynx™
K160982 · Eden Spine, LLC · Dec 2016