Cleared Traditional

K103414 - VENUS CERVICAL SPINAL FIXATION SYSTEM

K103414 is the FDA 510(k) clearance for VENUS CERVICAL SPINAL FIXATION SYSTEM by L & K Biomed Co., Ltd.. It is a Class 2 Orthopedic device (product code MNI) cleared through the Traditional 510(k) pathway after a 242-day FDA review.

K103414 · L & K Biomed Co., Ltd. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2011
Decision
242d
Days
Class 2
Risk

K103414 is an FDA 510(k) clearance for the VENUS CERVICAL SPINAL FIXATION SYSTEM. Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by L & K Biomed Co., Ltd. (Seoul, KR). The FDA issued a Cleared decision on July 22, 2011 after a review of 242 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 L & K Biomed Co., Ltd. devices

Submission Details

510(k) Number K103414 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 2010
Decision Date July 22, 2011
Days to Decision 242 days
Submission Type Traditional
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
120d slower than avg
Panel avg: 122d · This submission: 242d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 159
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K103414.
ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM
K112108 · Spineart · Aug 2011
ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM
K111127 · Spineart · Aug 2011
MESA SPINAL SYSTEM (KEYSTONE RODS)
K110991 · K2m, Inc. · Aug 2011
EXACTECH GIBRALT SPINAL SYSTEM
K110197 · Exactech, Inc. · Jul 2011
EVEREST SPINAL SYSTEM
K103440 · K2m, Inc. · Mar 2011
MOUNTAINEER OCT SPINAL SYSTEM
K103100 · Depuy Spine, Inc. · Nov 2010