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Found 6 results
510(k) Data Aggregation
K Number
K073274Device Name
SPINAL SPHERE SYSTEM
Manufacturer
LIFE SPINE
Date Cleared
2008-03-17
(117 days)
Product Code
NVR
Regulation Number
N/AWhy did this record match?
Product Code :
NVR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Spinal Sphere System is intended to be inserted between the vertebral bodies into the disc space from L3 to S1 to help provide stabilization and to help promote intervertebral body fusion. Properly used, this internal fixation device is intended and designed solely for holding bone parts in alignment while they heal. The Spinal Sphere System is intended to be used with bone graft. The indications and contraindications of spinal instrumentation systems should be well understood by the surgeon. It is not intended for use in motion-sparing, non-fusion procedures.
Device Description
The Spinal Sphere System consists of spheres manufactured from either CoCrMo or PEEK-OPTIMA. The device may be implanted from L3 to S1 to provide temporary stabilization in order to help promote fusion. The spheres are available in a variety of sizes.
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K Number
K073105Device Name
PEEK SPINAL SPHERES
Manufacturer
INTERBODY INNOVATIONS, LLP
Date Cleared
2008-01-03
(62 days)
Product Code
NVR
Regulation Number
N/AWhy did this record match?
Product Code :
NVR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Spinal Spheres are intended to be inserted between vertebral bodies into the disc space from L3 to S1 to help provide stabilization and to help promote intervertebral body fusion. This internal fixation device is intended for, and designed solely for holding bone parts in alignment while they heal. The Spinal Spheres are intended to be used with bone graft.
Device Description
These spheres may be inserted between the vertebral bodies into the disc space from L3 to S1. The Spinal Sphere implants are single use implants and should never be reused under any circumstances. These spheres are available in Ø10-Ø16mm.
Materials: PEEK Optima per ASTM F2026
Function: The Spinal Sphere is a spherical implant designed to hold bone parts in alignment while they heal in order to promote interbody fusion.
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K Number
K062992Device Name
SPINAL SPHERES
Manufacturer
INTERBODY INNOVATIONS LLP
Date Cleared
2007-07-27
(298 days)
Product Code
NVR
Regulation Number
N/AWhy did this record match?
Product Code :
NVR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Spinal Spheres are intended to be inserted between vertebral bodies into the disc space from L3 to S1 to help provide stabilization and to help promote intervertebral body fusion. This internal fixation device is intended for, and designed solely for holding bone parts in alignment while they heal. The Spinal Spheres are intended to be used with bone graft.
Device Description
The Spinal Spheres consist of CoCtMo spheres which may be implanted from L3 to S1 to 16 morary stabilization in order to promote fusion. These spheres are available in Ø10-Ø16mm diameters.
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K Number
K063139Device Name
SPINAL STABILIZING SPHERE SYSTEM
Manufacturer
BIOMET SPINE
Date Cleared
2007-04-04
(170 days)
Product Code
NVR
Regulation Number
N/AWhy did this record match?
Product Code :
NVR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Spinal Stabilizing Sphere System is intended to be inserted between the vertebral bodies into the disc space from L3 to S1 to help provide stabilization and to help promote intervertebral body fusion. This internal fixation device is intended for, and designed solely for holding bone parts in alignment while they heal. The Spinal Stabilizing Sphere System is intended to be used with bone graft.
Device Description
The Spinal Stabilizing Sphere System consists of two types of CoCrMo spheres (full and trimmed), which may be implanted from L3-S1 to provide temporary stabilization in order to help promote fusion.
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K Number
K060415Device Name
MODIFICATION TO: SATELLITE SPINAL SYSTEM
Manufacturer
MEDTRONIC SOFAMOR DANEK
Date Cleared
2007-01-05
(322 days)
Product Code
NVR
Regulation Number
N/AWhy did this record match?
Product Code :
NVR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SATELLITE™ Spinal System is intended to be inserted between the vertebral bodies into the disc space from L3 to S1 to help provide stabilization and to help promote intervertebral body fusion. This internal fixation device is intended for, and designed solely for holding bone parts in alignment while they heal. The SATELLITE™ Spinal System is intended to be used with bone graft.
Device Description
The SATELLITE™ Spinal System consists of spheres manufactured from either cobalt chrome or medical grade PEEK-OPTIMA LT1, which may be implanted from L3-S1 to provide temporary stabilization in order to help promote fusion.
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K Number
K051320Device Name
SATELLITE SPINAL SYSTEM
Manufacturer
MEDTRONIC SOFAMOR DANEK
Date Cleared
2005-09-09
(112 days)
Product Code
NVR
Regulation Number
N/AWhy did this record match?
Product Code :
NVR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SATELLITE™ Spinal System is intended to be inserted between the vertebral bodies into the disc space from L3 to S1 to help provide stabilization and to help promote intervertebral body fusion. This internal fixation device is intended for, and designed solely for holding bone parts in alignment while they heal. The SATELLITE™ Spinal System is intended to be used with bone graft.
Device Description
The SATELLITE™ Spinal System consists of cobalt chrome spheres, which may be implanted from L3-S1 to provide temporary stabilization in order to help promote fusion.
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