Cleared Special

K101151 - REGENT ANTERIOR CERVICAL PLATE

K101151 is an FDA 510(k) clearance for REGENT ANTERIOR CERVICAL PLATE, manufactured by Custom Spine. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Special 510(k) pathway after a 26-day FDA review.

K101151 · Custom Spine · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2010
Decision
26d
Days
Class 2
Risk

K101151 is an FDA 510(k) clearance for the REGENT ANTERIOR CERVICAL PLATE. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Custom Spine (Parsippany, US). The FDA issued a Cleared decision on May 19, 2010 after a review of 26 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.

FDA 510(k) Submission Details - K101151

510(k) Number K101151 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 2010
Decision Date May 19, 2010
Days to Decision 26 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 122d · This submission: 26d
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 662
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K101151.
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
TRANSCORP TRANS-PLATE ANTERIOR CERVICAL PLATE SYSTEM
K092695 · Transcorp, Inc. · May 2010
DIAMOND ANTERIOR CERVICAL PLATE SYSTEM
K100265 · Amendia, Inc. · 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
K101151 · REGENT ANTERIOR CERVICAL PLATE
Download PDF FDA Summary Custom Spine