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510(k) Data Aggregation
K Number
K102449Device Name
BRIGHT SPINE GALILEO SPINAL SPACER SYSTEM
Manufacturer
BRIGHT SPINE, INC
Date Cleared
2011-02-11
(168 days)
Product Code
ODP
Regulation Number
888.3080Why did this record match?
Applicant Name (Manufacturer) :
BRIGHT SPINE, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
When used as a cervical intervertebral body fusion device, the Galileo™ Spinal Spacer System is intended for spinal fusion procedures at one level (C2 to T1) in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be packed with autogenous bone graft. These patients should have had six months of non-operative treatment. The Galileo™ Spinal Spacer System is to be used with a supplemental fixation system.
Device Description
The Bright Spine Galileo™ Spinal Spacer System is an implantable device manufactured from titanium alloy
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