Cleared Special

K132644 - LOSPA IS PEDICLE SCREW (MONOAXIAL & POLYAXIAL), LOSPA IS ROD- STRAIGHT (STANDARD), LOSPA IS ROD- PRE BENT (STANDARD & BU

K132644 is an FDA 510(k) clearance for LOSPA IS PEDICLE SCREW (MONOAXIAL & POL..., manufactured by Corentec Co., Ltd.. The device is a Class 2 Orthopedic device with product code MNI cleared through the Special 510(k) pathway after a 24-day FDA review.

K132644 · Corentec Co., Ltd. · Orthopedic device
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Sep 2013
Decision
24d
Days
Class 2
Risk

K132644 is an FDA 510(k) clearance for the LOSPA IS PEDICLE SCREW (MONOAXIAL & POLYAXIAL), LOSPA IS ROD- STRAIGHT (STAND.... Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by Corentec Co., Ltd. (Seocho Gu, Seoul, KR). The FDA issued a Cleared decision on September 19, 2013 after a review of 24 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 Corentec Co., Ltd. devices

FDA 510(k) Submission Details - K132644

510(k) Number K132644 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 2013
Decision Date September 19, 2013
Days to Decision 24 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
98d faster than avg
Panel avg: 122d · This submission: 24d
Pathway characteristics
Modification to existing cleared device.

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 265
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K132644.
TRUE SPINAL FIXATION SYSTEM
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K132412 · Nexxt Spine, LLC · Oct 2013
EVEREST SPINAL SYSTEM
K132361 · K2m, Inc. · Oct 2013
SPONDYLOLISTHESIS SPINAL FIXATION, SPINAL PEDICLE FIXATION
K132365 · Accel Spine · Aug 2013
CORE PEDICLE SCREW SYSTEM
K131522 · Core-Nexus · Aug 2013
CAPSURE PS SYSTEM
K132154 · Spine Wave, Inc. · Aug 2013