Cleared Traditional

K093104 - MEDYSSEY CO.

K093104 is an FDA 510(k) clearance for MEDYSSEY CO., manufactured by Medyssey Co, Ltd.. The device is a Class 2 Orthopedic device with product code MNI cleared through the Traditional 510(k) pathway after a 267-day FDA review.

K093104 · Medyssey Co, Ltd. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2010
Decision
267d
Days
Class 2
Risk

K093104 is an FDA 510(k) clearance for the MEDYSSEY CO., LTD., ZENIUS SPINAL SYSTEM. Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by Medyssey Co, Ltd. (Murray, US). The FDA issued a Cleared decision on June 25, 2010 after a review of 267 days - an extended review cycle.

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 Medyssey Co, Ltd. devices

FDA 510(k) Submission Details - K093104

510(k) Number K093104 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 2009
Decision Date June 25, 2010
Days to Decision 267 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
145d slower than avg
Panel avg: 122d · This submission: 267d
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 187
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K093104.
LIFE SPINE INTERSPINOUS FIXATION SYSTEM
K100407 · Life Spine · Nov 2010
LDR SPINE USA SPINETUNE TL SPINAL SYSTEM
K102331 · Ldr Spine USA · Oct 2010
RANGE SPINAL SYSTEM
K100851 · K2m, Inc. · Aug 2010
AEGIS & AEGIS II SPINAL SYSTEM
K092076 · Corentec Co., Ltd. · Apr 2010
LDR SPINE USA SPINE TUNE TL SPINE SYSTEM
K100575 · Ldr Spine USA · Mar 2010
ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM
K093936 · Spineart · Mar 2010