Cleared Traditional

K100265 - DIAMOND ANTERIOR CERVICAL PLATE SYSTEM

K100265 is an FDA 510(k) clearance for DIAMOND ANTERIOR CERVICAL PLATE SYSTEM, manufactured by Amendia, Inc.. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K100265 · Amendia, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2010
Decision
104d
Days
Class 2
Risk

K100265 is an FDA 510(k) clearance for the DIAMOND ANTERIOR CERVICAL PLATE SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Amendia, Inc. (Marietta, US). The FDA issued a Cleared decision on May 13, 2010 after a review of 104 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 Amendia, Inc. devices

FDA 510(k) Submission Details - K100265

510(k) Number K100265 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 2010
Decision Date May 13, 2010
Days to Decision 104 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
18d faster than avg
Panel avg: 122d · This submission: 104d
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 491
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K100265.
ALPHATEC SPINE ANTERIOR LUMBAR PLATING SYSTEM
K101255 · Alphatec Spine, Inc. · Jul 2010
PIONEER ANTERIOR CERVICAL PLATE MODEL 24-SERIES
K100708 · Pioneer Surgical Technology · Jun 2010
MAMBO, MODEL CS 18XX-XX
K090861 · Ulrich GmbH & Co. KG · May 2010
HALLMARK ANTERIOR CERVCIAL PLATE SYSTEM, HALLMARK FIVE-LEVEL CERVICAL PLATES
K100614 · Blackstone Medical, Inc. · May 2010
LANX ANTERIOR PLATING SYSTEM
K092765 · Lanx, Inc. · Apr 2010
INDUS ANTERIOR CERVICAL PLATE SYSTEM
K093776 · Spinefrontier, Inc. · Mar 2010