Cleared Traditional

K063708 - 4S SPINAL SYSTEM

K063708 is an FDA 510(k) clearance for 4S SPINAL SYSTEM, manufactured by Taeyeon Medical Co., Ltd.. The device is a Class 2 Orthopedic device with product code MNI cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K063708 · Taeyeon Medical Co., Ltd. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2007
Decision
132d
Days
Class 2
Risk

K063708 is an FDA 510(k) clearance for the 4S SPINAL SYSTEM. Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by Taeyeon Medical Co., Ltd. (Incheon, KR). The FDA issued a Cleared decision on April 24, 2007 after a review of 132 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 Taeyeon Medical Co., Ltd. devices

FDA 510(k) Submission Details - K063708

510(k) Number K063708 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 2006
Decision Date April 24, 2007
Days to Decision 132 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
10d slower than avg
Panel avg: 122d · This submission: 132d
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 K063708.
NUVASIVE OCT SYSTEM
K071435 · Nuvasive, Inc. · Aug 2007
ROC LUMBAR SYSTEM
K063668 · Alphatec Spine, Inc. · May 2007
RANGE SPINAL SYSTEM
K070229 · K2m, Inc. · May 2007
CAPSURE PEDICLE SCREW SYSTEM
K070245 · Spine Wave, Inc. · Apr 2007
PILOT SPINAL SYSTEM
K063601 · Life Spine · Jan 2007
MODIFICATION TO EASYSPINE SYSTEM
K063794 · Ldr Spine USA · Jan 2007