Cleared Special

K162801 - CastleLoc Spinal Fixation System

K162801 is an FDA 510(k) clearance for CastleLoc Spinal Fixation System, manufactured by L & K Biomed Co., Ltd.. The device is a Class 2 Orthopedic device with product code MNH cleared through the Special 510(k) pathway after a 29-day FDA review.

K162801 · L & K Biomed Co., Ltd. · Orthopedic device
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Nov 2016
Decision
29d
Days
Class 2
Risk

K162801 is an FDA 510(k) clearance for the CastleLoc Spinal Fixation System. Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by L & K Biomed Co., Ltd. (Yongin-Si, KR). The FDA issued a Cleared decision on November 3, 2016 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all L & K Biomed Co., Ltd. devices

FDA 510(k) Submission Details - K162801

510(k) Number K162801 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 2016
Decision Date November 03, 2016
Days to Decision 29 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
93d faster than avg
Panel avg: 122d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

MNH Device Classification - Class 2, Special Controls

Product Code MNH Orthosis, Spondylolisthesis Spinal Fixation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
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 - MNH Orthosis, Spondylolisthesis Spinal Fixation

All 260
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K162801.
Reliance Spinal Screw System
K162066 · Reliance Medical Systems, LLC · Dec 2016
FixxSure® X-Link
K162143 · Innovasis, Inc. · Sep 2016
Spinal fixation system
K161151 · Canwell Medical Co., Ltd. · Sep 2016
ANAX™ 5.5 Spinal System
K162189 · U&I Corporation · Aug 2016
HC Spinal System
K151362 · Hung Chun Bio-S Co., Ltd. · May 2016
Zavation Spinal System
K153404 · Zavation, LLC · Apr 2016