Cleared Traditional

K140734 - NEXTGEN ALTIUS OCT SYSTEM

K140734 is an FDA 510(k) clearance for NEXTGEN ALTIUS OCT SYSTEM, manufactured by Ebi, LLC. The device is a Class 2 Orthopedic device with product code KWP cleared through the Traditional 510(k) pathway after a 266-day FDA review.

K140734 · Ebi, LLC · Orthopedic device
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Dec 2014
Decision
266d
Days
Class 2
Risk

K140734 is an FDA 510(k) clearance for the NEXTGEN ALTIUS OCT SYSTEM. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Ebi, LLC (Parsippany, US). The FDA issued a Cleared decision on December 15, 2014 after a review of 266 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3050 - 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 Ebi, LLC devices

FDA 510(k) Submission Details - K140734

510(k) Number K140734 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 2014
Decision Date December 15, 2014
Days to Decision 266 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
144d slower than avg
Panel avg: 122d · This submission: 266d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWP Device Classification - Class 2, Special Controls

Product Code KWP Appliance, Fixation, Spinal Interlaminal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3050
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 - KWP Appliance, Fixation, Spinal Interlaminal

All 337
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K140734.
SOLSTICE OCT System
K143249 · Life Spine, Inc. · Apr 2015
SOLSTICE OCT System
K150229 · Life Spine, Inc. · Apr 2015
OASYS System
K142741 · Stryker Corporation · Jan 2015
SYNAPSE SYSTEM, SYNTHES OC FUSION SYSTEM
K141897 · Synthes USA Products, LLC · Sep 2014
CASPIAN SPINAL SYSTEM
K141284 · K2m, Inc. · Jul 2014
CASPIAN OCT SPINAL SYSTEM
K133288 · K2m, Inc. · Jul 2014