Cleared Traditional

K102449 - BRIGHT SPINE GALILEO SPINAL SPACER SYSTEM

K102449 is an FDA 510(k) clearance for BRIGHT SPINE GALILEO SPINAL SPACER SYSTEM, manufactured by Bright Spine, Inc.. The device is a Class 2 Orthopedic device with product code ODP cleared through the Traditional 510(k) pathway after a 168-day FDA review.

K102449 · Bright Spine, Inc. · Orthopedic device
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Feb 2011
Decision
168d
Days
Class 2
Risk

K102449 is an FDA 510(k) clearance for the BRIGHT SPINE GALILEO SPINAL SPACER SYSTEM. Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by Bright Spine, Inc. (Boca Raton, US). The FDA issued a Cleared decision on February 11, 2011 after a review of 168 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3080 - 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 Bright Spine, Inc. devices

FDA 510(k) Submission Details - K102449

510(k) Number K102449 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 2010
Decision Date February 11, 2011
Days to Decision 168 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
46d slower than avg
Panel avg: 122d · This submission: 168d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ODP Device Classification - Class 2, Special Controls

Product Code ODP Intervertebral Fusion Device With Bone Graft, Cervical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize Cervical Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft.
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 - ODP Intervertebral Fusion Device With Bone Graft, Cervical

All 267
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K102449.
OCTANE-C INTERBODY FUSION DEVICE SYSTEM
K103655 · Exactech, Inc. · Jun 2011
ALEUTTIAN
K103169 · K2m, Inc. · Mar 2011
LANX CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM
K103660 · Lanx, Inc. · Feb 2011
ORTHOVITA PEEK SPACER
K101171 · Orthovita, Inc. · Jan 2011
SMALL PLATEAU SPACER SYSTEM
K093093 · Life Spine · Oct 2010
CONSTRUX MINI PEEK SPACER SYSTEM
K101812 · Orthofix, Inc. · Sep 2010