Cleared Traditional

K050082 - CENTERPIECE PLATE FIXATION SYSTEM

K050082 is an FDA 510(k) clearance for CENTERPIECE PLATE FIXATION SYSTEM, manufactured by Medtronic Sofamor Danek, Inc.. The device is a Class 2 Orthopedic device with product code NQW cleared through the Traditional 510(k) pathway after a 144-day FDA review.

K050082 · Medtronic Sofamor Danek, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2005
Decision
144d
Days
Class 2
Risk

K050082 is an FDA 510(k) clearance for the CENTERPIECE PLATE FIXATION SYSTEM. Classified as Orthosis, Spine, Plate, Laminoplasty, Metal (product code NQW), Class II - Special Controls.

Submitted by Medtronic Sofamor Danek, Inc. (Memphis, US). The FDA issued a Cleared decision on June 6, 2005 after a review of 144 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3050 - 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 Medtronic Sofamor Danek, Inc. devices

FDA 510(k) Submission Details - K050082

510(k) Number K050082 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 2005
Decision Date June 06, 2005
Days to Decision 144 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
22d slower than avg
Panel avg: 122d · This submission: 144d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NQW Device Classification - Class 2, Special Controls

Product Code NQW Orthosis, Spine, Plate, Laminoplasty, Metal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3050
Definition This Device Is A Plate That Is Attached To The Lamina After A Laminoplasty Or Laminectomy Procedure.
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 - NQW Orthosis, Spine, Plate, Laminoplasty, Metal

All 28
Devices cleared under the same product code (NQW) and FDA review panel - the closest regulatory comparables to K050082.
LAMINOPLASTY FIXATION SYSTEM
K091623 · Nuvasive, Inc. · Oct 2009
LAMINOPLASTY PLATING SYSTEM
K090354 · Aesculap Implant System, Inc. · May 2009
RELIEVE LAMINOPLASTY FIXATION SYSTEM
K080664 · Globus Medical, Inc. · Jul 2008
BLAKSTONE LAMINOPLASTY FIXATION SYSTEM
K043338 · Blackstone Medical, Inc. · Feb 2005
SYNTHES AFS
K032534 · Synthes Spine · Apr 2004