Cleared Special

K062912 - SCIENT'X SPINAL SYSTEM

K062912 is an FDA 510(k) clearance for SCIENT'X SPINAL SYSTEM, manufactured by Scient'X. The device is a Class 2 Orthopedic device with product code MNI cleared through the Special 510(k) pathway after a 131-day FDA review.

K062912 · Scient'X · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2007
Decision
131d
Days
Class 2
Risk

K062912 is an FDA 510(k) clearance for the SCIENT'X SPINAL SYSTEM. Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by Scient'X (Round Rock, US). The FDA issued a Cleared decision on February 5, 2007 after a review of 131 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K062912

510(k) Number K062912 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2006
Decision Date February 05, 2007
Days to Decision 131 days
Submission Type Special
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
9d slower than avg
Panel avg: 122d · This submission: 131d
Pathway characteristics
Modification to existing cleared device.

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 302
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K062912.
RANGE SPINAL SYSTEM
K070229 · K2m, Inc. · May 2007
4S SPINAL SYSTEM
K063708 · Taeyeon Medical Co., Ltd. · Apr 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
TRAVERSE OCT SPINAL FIXATION SYSTEM
K062879 · Medtronic Sofamor Danek, Inc. · Dec 2006
K062912 · SCIENT'X SPINAL SYSTEM
Download PDF FDA Summary Scient'X