Cleared Traditional

K062083 - SYNFIX -LR

K062083 is an FDA 510(k) clearance for SYNFIX -LR, manufactured by Synthes Spine Co.Lp. The device is a Class 2 Orthopedic device with product code MQP cleared through the Traditional 510(k) pathway after a 256-day FDA review.

K062083 · Synthes Spine Co.Lp · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2007
Decision
256d
Days
Class 2
Risk

K062083 is an FDA 510(k) clearance for the SYNFIX -LR. Classified as Spinal Vertebral Body Replacement Device (product code MQP), Class II - Special Controls.

Submitted by Synthes Spine Co.Lp (West Chester, US). The FDA issued a Cleared decision on April 3, 2007 after a review of 256 days - an extended review 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: 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 Synthes Spine Co.Lp devices

FDA 510(k) Submission Details - K062083

510(k) Number K062083 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 2006
Decision Date April 03, 2007
Days to Decision 256 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
134d slower than avg
Panel avg: 122d · This submission: 256d
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 197
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K062083.
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
VERTE-STACK SPINAL SYSTEM
K070173 · Medtronic Sofamor Danek, Inc. · Mar 2007
T2 SCEPTOR SPINAL SYSTEM
K063491 · Medtronic Sofamor Danek · Mar 2007
ALEUTIAN SPACER SYSTEM
K063399 · K2m, Inc. · Feb 2007