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510(k) Data Aggregation
K Number
K201751Device Name
Pedicle Screw System
Manufacturer
Black Box Medical LLC
Date Cleared
2020-07-22
(26 days)
Product Code
NKB
Regulation Number
888.3070Why did this record match?
Applicant Name (Manufacturer) :
Black Box Medical LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Pedicle Screw System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities of thoracic, lumbar, and sacral spine: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; tumor; pseudoarthrosis; and failed previous fusion.
Device Description
The Pedicle Screw System consists of longitudinal rods, polyaxial screws, and transverse connectors. It is manufactured from Ti-6Al-4V alloy conforming to ASTM F136.
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K Number
K182283Device Name
FUSE Pedicle Screw System
Manufacturer
Black Box Medical
Date Cleared
2018-10-23
(61 days)
Product Code
NKB
Regulation Number
888.3070Why did this record match?
Applicant Name (Manufacturer) :
Black Box Medical
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The FUSE Pedicle Screw System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities of thoracic, lumbar, and sacral spine: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; tumor; pseudoarthrosis; and failed previous fusion.
Device Description
The FUSE Pedicle Screw System consists of longitudinal rods and polyaxial screws. It is manufactured from Ti-6Al-4V alloy conforming to ASTM F136.
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K Number
K181554Device Name
Stowe Pedicle Screw System
Manufacturer
Black Box Medical
Date Cleared
2018-07-27
(44 days)
Product Code
NKB
Regulation Number
888.3070Why did this record match?
Applicant Name (Manufacturer) :
Black Box Medical
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Stowe Pedicle Screw System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities of thoracic, lumbar, and sacral spine: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; tumor; pseudoarthrosis; and failed previous fusion.
Device Description
The STOWE Pedicle Screw System consists of longitudinal rods, polyaxial screws, and transverse connectors. It is manufactured from Ti-6Al-4V alloy conforming to ASTM F136.
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