Cleared Traditional

K100805 - GALLERY LAMINOPLASTY FIXATION SYSTEM

K100805 is an FDA 510(k) clearance for GALLERY LAMINOPLASTY FIXATION SYSTEM, manufactured by Biomet Spine (Aka Ebi, LLC). The device is a Class 2 Orthopedic device with product code NQW cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K100805 · Biomet Spine (Aka Ebi, LLC) · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2010
Decision
120d
Days
Class 2
Risk

K100805 is an FDA 510(k) clearance for the GALLERY LAMINOPLASTY FIXATION SYSTEM. Classified as Orthosis, Spine, Plate, Laminoplasty, Metal (product code NQW), Class II - Special Controls.

Submitted by Biomet Spine (Aka Ebi, LLC) (Parsippany, US). The FDA issued a Cleared decision on July 20, 2010 after a review of 120 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 Biomet Spine (Aka Ebi, LLC) devices

FDA 510(k) Submission Details - K100805

510(k) Number K100805 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 2010
Decision Date July 20, 2010
Days to Decision 120 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
2d faster than avg
Panel avg: 122d · This submission: 120d
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 26
Devices cleared under the same product code (NQW) and FDA review panel - the closest regulatory comparables to K100805.
ESCALATE LAMINOPLASTY SYSTEM
K113802 · Stryker Spine · Apr 2012
PIONEER RELEASE LAMINOPLASTY PLATING SYSTEM
K113218 · Pioneer Surgical Technology, Inc. · Jan 2012
LAMINOPLASY PLATING SYSTEM
K103284 · Aesculap Implant Systems, Inc. · Dec 2010
MOUNTAINEER LAMINOPLASTY SYSTEM
K091994 · Depuy Spine, Inc. · Jan 2010
LAMINOPLASTY FIXATION SYSTEM
K091623 · Nuvasive, Inc. · Oct 2009
LAMINOPLASTY PLATING SYSTEM
K090354 · Aesculap Implant System, Inc. · May 2009