Cleared Traditional

K130073 - MIKRON SPINAL FIXATION SYSTEM

K130073 is an FDA 510(k) clearance for MIKRON SPINAL FIXATION SYSTEM, manufactured by Mikron Makina Sanayi VE Ticaret Ltd. Sti.. The device is a Class 2 Orthopedic device with product code MNI cleared through the Traditional 510(k) pathway after a 339-day FDA review.

K130073 · Mikron Makina Sanayi VE Ticaret Ltd. Sti. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Dec 2013
Decision
339d
Days
Class 2
Risk

K130073 is an FDA 510(k) clearance for the MIKRON SPINAL FIXATION SYSTEM, POLYXIAL PEDICLE SCREWS, SET SCREWS, LONGITUDI.... Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by Mikron Makina Sanayi VE Ticaret Ltd. Sti. (Chesapeake City, US). The FDA issued a Cleared decision on December 16, 2013 after a review of 339 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Mikron Makina Sanayi VE Ticaret Ltd. Sti. devices

FDA 510(k) Submission Details - K130073

510(k) Number K130073 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 2013
Decision Date December 16, 2013
Days to Decision 339 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
217d slower than avg
Panel avg: 122d · This submission: 339d
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 185
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K130073.
ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM PREBENT CROSS-CONNECTORS
K141835 · Spineart · Sep 2014
SURE-LOK C EXTENDED TAB PEDICLE SCREW SYSTEM
K141397 · Precision Spine, Inc. · Jun 2014
MYSPINE PEDICLE SCREW PLACEMENT GUIDES
K132788 · Medacta International · May 2014
EVEREST SPINAL SYSTEM
K132757 · K2m, Inc. · Nov 2013
EVEREST SPINAL SYSTEM
K132361 · K2m, Inc. · Oct 2013
LOSPA IS PEDICLE SCREW (MONOAXIAL & POLYAXIAL), LOSPA IS ROD- STRAIGHT (STANDARD), LOSPA IS ROD- PRE BENT (STANDARD & BU
K132644 · Corentec Co., Ltd. · Sep 2013