Cleared Traditional

K103505 - ALTUM ANTERIOR CERVICAL PLATE

K103505 is an FDA 510(k) clearance for ALTUM ANTERIOR CERVICAL PLATE, manufactured by Spinecraft, LLC. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K103505 · Spinecraft, LLC · Orthopedic device
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Mar 2011
Decision
106d
Days
Class 2
Risk

K103505 is an FDA 510(k) clearance for the ALTUM ANTERIOR CERVICAL PLATE. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Spinecraft, LLC (Westchester, US). The FDA issued a Cleared decision on March 15, 2011 after a review of 106 days - within the typical 510(k) review window.

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 Spinecraft, LLC devices

FDA 510(k) Submission Details - K103505

510(k) Number K103505 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 2010
Decision Date March 15, 2011
Days to Decision 106 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
16d faster than avg
Panel avg: 122d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWQ Device Classification - Class 2, Special Controls

Product Code KWQ Appliance, Fixation, Spinal Intervertebral Body
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 - KWQ Appliance, Fixation, Spinal Intervertebral Body

All 471
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K103505.
NUVASIVE ANTERIOR LUMBAR PLATE SYSTEM
K111866 · Nuvasive, Inc. · Jul 2011
NUVASIVE LONG LATERAL SPINAL SYSTEM
K111410 · Nuvasive, Inc. · Jun 2011
MIS ANTERIOR CERVICAL PLATING SYSTEM
K103423 · Life Spine · Jun 2011
NUVASIVE TRAVERSE PLATE SYSTEM
K103750 · Nuvasive, Inc. · Mar 2011
GOLDEN GATE ANTERIOR PLATE SYSTEM
K101353 · Ulrich GmbH & Co. KG · Feb 2011
APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
K102820 · Alphatec Spine, Inc. · Nov 2010