Cleared Special

K050892 - HALLMARKTM ANTERIOR CERVICAL PLATE SYSTEM

K050892 is an FDA 510(k) clearance for HALLMARKTM ANTERIOR CERVICAL PLATE SYSTEM, manufactured by Blackstone Medical, Inc.. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Special 510(k) pathway after a 33-day FDA review.

K050892 · Blackstone Medical, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2005
Decision
33d
Days
Class 2
Risk

K050892 is an FDA 510(k) clearance for the HALLMARKTM ANTERIOR CERVICAL PLATE SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Blackstone Medical, Inc. (Springfield, US). The FDA issued a Cleared decision on May 11, 2005 after a review of 33 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Blackstone Medical, Inc. devices

FDA 510(k) Submission Details - K050892

510(k) Number K050892 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 2005
Decision Date May 11, 2005
Days to Decision 33 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
89d faster than avg
Panel avg: 122d · This submission: 33d
Pathway characteristics
Modification to existing cleared device.

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 612
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K050892.
BLACKSTONE UNITY ANTERIOR LUMBAR PLATE FIXATION SYSTEM
K043548 · Blackstone Medical, Inc. · Jun 2005
TRANS1 AXIALIF SYSTEM
K050965 · Trans1 Incorporated · Jun 2005
BASIS SPINAL SYSTEM
K051039 · Medtronic Sofamor Danek USA, Inc. · May 2005
ABC 2 SCREW
K050813 · Aesculap, Inc. · May 2005
VERTEVIEW ANTERIOR CERVICAL PLATE SYSTEM
K050588 · Innovative Spinal Design, LLC · Apr 2005
LANX ANTERIOR CERVICAL PLATE SYSTEM
K050774 · Lanx, LLC · Apr 2005