Cleared Traditional

K101848 - SAPPHIRE ANTERIOR CERVICAL PLATE SYSTEM

K101848 is an FDA 510(k) clearance for SAPPHIRE ANTERIOR CERVICAL PLATE SYSTEM, manufactured by Spinal Elements, Inc.. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K101848 · Spinal Elements, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2010
Decision
105d
Days
Class 2
Risk

K101848 is an FDA 510(k) clearance for the SAPPHIRE ANTERIOR CERVICAL PLATE SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Spinal Elements, Inc. (Carlsbad, US). The FDA issued a Cleared decision on October 14, 2010 after a review of 105 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 Spinal Elements, Inc. devices

FDA 510(k) Submission Details - K101848

510(k) Number K101848 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2010
Decision Date October 14, 2010
Days to Decision 105 days
Submission Type Traditional
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
17d faster than avg
Panel avg: 122d · This submission: 105d
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 615
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K101848.
GOLDEN GATE ANTERIOR PLATE SYSTEM
K101353 · Ulrich GmbH & Co. KG · Feb 2011
POLARIS SPINAL SYSTEM
K103393 · Biomet Spine · Feb 2011
APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
K102820 · Alphatec Spine, Inc. · Nov 2010
LDR SPINE USA C-PLATE, TL ANTERIOR CERVICAL PLATE SYSTEM
K102265 · Ldr Spine USA · Sep 2010
QUINTEX CERVICAL PLATING SYSTEM
K100243 · Aesculap Implant Systems, LLC · Sep 2010
ALPHATEC SPINE ANTERIOR LUMBAR PLATING SYSTEM
K101255 · Alphatec Spine, Inc. · Jul 2010