Cleared Traditional

K102574 - PALLA M SPINAL SYSTEM

K102574 is an FDA 510(k) clearance for PALLA M SPINAL SYSTEM, manufactured by Korea Bone Bank Co., Ltd.. The device is a Class 2 Orthopedic device with product code MNH cleared through the Traditional 510(k) pathway after a 180-day FDA review.

K102574 · Korea Bone Bank Co., Ltd. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2011
Decision
180d
Days
Class 2
Risk

K102574 is an FDA 510(k) clearance for the PALLA M SPINAL SYSTEM. Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by Korea Bone Bank Co., Ltd. (Brea, US). The FDA issued a Cleared decision on March 7, 2011 after a review of 180 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 Korea Bone Bank Co., Ltd. devices

FDA 510(k) Submission Details - K102574

510(k) Number K102574 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 2010
Decision Date March 07, 2011
Days to Decision 180 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
58d slower than avg
Panel avg: 122d · This submission: 180d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MNH Device Classification - Class 2, Special Controls

Product Code MNH Orthosis, Spondylolisthesis Spinal 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 - MNH Orthosis, Spondylolisthesis Spinal Fixation

All 189
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K102574.
PASS LP SPINAL SYSTEM
K110497 · Medicrea International · Sep 2011
4CIS SOLAR SPINE SYSTEM AND 4CIS APOLLON SPINE SYSTEM
K102458 · Solco Biomedical Co., Ltd. · Jun 2011
TIGER SPINE SYSTEM
K110321 · Corelink, LLC · May 2011
4CIS VANE SPINE SYSTEM
K101818 · Solco Biomedical Co., Ltd. · Feb 2011
VENUS BASIC SPINAL FIXATION SYSTEM
K103085 · L & K Biomed Co., Ltd. · Feb 2011
FLAMENCO SPINAL FIXATION SYSTEM
K102853 · Ulrich GmbH & Co. KG · Jan 2011