Cleared Traditional

K070181 - SINTEA BIOTECH DSC/ALF SPINAL SYSTEM, DSC.XX.T5.XX, ALF.XX.T5.XX

K070181 is an FDA 510(k) clearance for SINTEA BIOTECH DSC/ALF SPINAL SYSTEM, manufactured by Sintea Biotech, Inc.. The device is a Class 2 Orthopedic device with product code MQP cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K070181 · Sintea Biotech, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2007
Decision
89d
Days
Class 2
Risk

K070181 is an FDA 510(k) clearance for the SINTEA BIOTECH DSC/ALF SPINAL SYSTEM, DSC.XX.T5.XX, ALF.XX.T5.XX. Classified as Spinal Vertebral Body Replacement Device (product code MQP), Class II - Special Controls.

Submitted by Sintea Biotech, Inc. (Miami Beach, US). The FDA issued a Cleared decision on April 18, 2007 after a review of 89 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Sintea Biotech, Inc. devices

FDA 510(k) Submission Details - K070181

510(k) Number K070181 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 2007
Decision Date April 18, 2007
Days to Decision 89 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
33d faster than avg
Panel avg: 122d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MQP Device Classification - Class 2, Special Controls

Product Code MQP Spinal Vertebral Body Replacement Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3060
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 - MQP Spinal Vertebral Body Replacement Device

All 212
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K070181.
X-POD ADJUSTABLE VERTEBRAL BODY REPLACEMENT
K070786 · Theken Spine, LLC · Jun 2007
SMALL STATURE SPACERS
K063393 · Biomet Spine · Jun 2007
THEKEN VU MESH VBR SYSTEM
K070381 · Theken Spine, LLC · Apr 2007
SYNFIX -LR
K062083 · Synthes Spine Co.Lp · Apr 2007
VERTE-STACK SPINAL SYSTEM
K070173 · Medtronic Sofamor Danek, Inc. · Mar 2007
ATLAS SPINE VERTEBRAL BODY REPLACEMENT
K063464 · Atlas Spine, Inc. · Mar 2007