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510(k) Data Aggregation
K Number
K072029Device Name
PHENIX VERTEBRAL BODY REPLACEMENT
Manufacturer
NEW BUSINESS DEVELOPMENT, LLC
Date Cleared
2007-10-15
(83 days)
Product Code
MQP
Regulation Number
888.3060Why did this record match?
Applicant Name (Manufacturer) :
NEW BUSINESS DEVELOPMENT, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Phenix™ VBR is a vertebral body replacement device intended for use in the thoracic spine (i.e., T1-L5) to replace a collapsed, damaged or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy) due to tumor or trauma (i.e., fracture). The Phenix™ VBR is designed to restore the mechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. The Phenix™ VBR is intended for use with supplemental spinal fixation systems that have been labeled for use in the thoracic spine. The interior of the Phenix™ VBR may be packed with bone graft.
Device Description
The Phenix™ VBR is a rectangular implant with an open center comprised of titanium, (Ti-6Al-4V). The Phenix™ VBR's superior and inferior ends have ridges to interface with the vertebral endplates to resist rotation and migration. The implant is available in a range of sizes, as well as flat and lordotic angled implants to accommodate variations in patient's anatomy. The Titanium allows for radiographic visualization.
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K Number
K050377Device Name
NBD HEAD SCREW
Manufacturer
NEW BUSINESS DEVELOPMENT, LLC
Date Cleared
2005-04-07
(51 days)
Product Code
HAW
Regulation Number
882.4560Why did this record match?
Applicant Name (Manufacturer) :
NEW BUSINESS DEVELOPMENT, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NBD Head Screws are an accessory that is intended to support the head frame in stereotactic procedures. The head frames are supported by either a three point-of-contact or four point-of-contact position depending on the frame design.
Device Description
The NBD Head Screw is a single-use threaded clear anodized aluminum screw which is manufactured in lengths ranging from 33mm-57mm.
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K Number
K032196Device Name
NBD DISPOSABLE RF CANNULAE
Manufacturer
NEW BUSINESS DEVELOPMENT, LLC
Date Cleared
2003-10-09
(83 days)
Product Code
GXI, GXD
Regulation Number
882.4725Why did this record match?
Applicant Name (Manufacturer) :
NEW BUSINESS DEVELOPMENT, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NBD Disposable RF Needle are indicated for use in radio frequency heat lesion procedures for relief of pain.
Device Description
Not Found
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K Number
K021788Device Name
NBD CEMENT RESTRICTOR DEVICE
Manufacturer
NEW BUSINESS DEVELOPMENT, LLC
Date Cleared
2002-10-04
(126 days)
Product Code
JDK
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
NEW BUSINESS DEVELOPMENT, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NBD Cement Restrictor Device is intended for use as a cement restrictor in orthopedic surgeries such as those involving the femoral canal and tibial plateau in hip stem and total knee replacement. The NBD Cement Restrictor is NOT intended for any spinal indications.
Device Description
The NBD Cement Restrictor Device is a hollow, titanium, rounded rectangular frame with fenestrated surfaces on all sides and 1mm toothed spikes on opposite sides. The device is intended to be used in conjunction with standard PMMA cement.
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