Cleared Traditional

K111883 - SMARTLOC SPINAL FIXATION SYSTEM

K111883 is an FDA 510(k) clearance for SMARTLOC SPINAL FIXATION SYSTEM, manufactured by A-Spine Asia, Co., Ltd.. The device is a Class 2 Orthopedic device with product code MNI cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K111883 · A-Spine Asia, Co., Ltd. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2011
Decision
109d
Days
Class 2
Risk

K111883 is an FDA 510(k) clearance for the SMARTLOC SPINAL FIXATION SYSTEM. Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by A-Spine Asia, Co., Ltd. (Taipei, Neihu District, TW). The FDA issued a Cleared decision on October 18, 2011 after a review of 109 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - 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 A-Spine Asia, Co., Ltd. devices

FDA 510(k) Submission Details - K111883

510(k) Number K111883 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2011
Decision Date October 18, 2011
Days to Decision 109 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
13d faster than avg
Panel avg: 122d · This submission: 109d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MNI Device Classification - Class 2, Special Controls

Product Code MNI Orthosis, Spinal Pedicle 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 - MNI Orthosis, Spinal Pedicle Fixation

All 199
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K111883.
RELIANCE SPINAL SCREW SYSTEM
K110896 · Reliance Medical Systems, LLC · Jan 2012
RANGE SPINAL SYSTEM (MESA AND DENALI)
K112920 · K2m, Inc. · Dec 2011
PASS LP SPINAL SYSTEM
K112493 · Medicrea International · Nov 2011
RANGE SPINAL SYSTEM (MESA AND DENALI)
K112037 · K2m, Inc. · Oct 2011
CAPSURE(R) PS SYSTEM
K111913 · Spine Wave, Inc. · Aug 2011
ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM
K112108 · Spineart · Aug 2011