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510(k) Data Aggregation
K Number
K150507Device Name
Santis Pedicle Screw System
Manufacturer
Date Cleared
2015-04-03
(36 days)
Regulation Number
888.3070Why did this record match?
Applicant Name (Manufacturer) :
LANTERNA MEDICAL TECHNOLOGIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Santis Pedicle Screw System is intended for immobilization of the spine. The Santis Pedicle Screw System is indicated for posterical pedicle fixation as an adjunct to fusion in skeletally mature patients using autograft and/or allograft for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
Device Description
The Santis™ Pedicle Screw System is comprised of: straight and pre-curved rods, pedicle screw assemblies with both cannulated and non-cannulated screws, compression retaining assemblies, cross connectors and a set screw. Various forms and sizes of these implants are available so that adaptations can be utilized to take into account the unique pathology of individual patients. The Santis™ Pedicle Screw System can be implanted either by an open procedure or percutaneous MIS approach, or a combination of both during the same procedure. Components are made of Ti6Al4V ELI, a titanium based alloy, which complies with ASTM F136, or cobalt chrome per ASTM F1537.
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K Number
K133063Device Name
SANTIS PEDICLE SCREW SYSTEM
Manufacturer
Date Cleared
2014-01-13
(108 days)
Regulation Number
888.3070Why did this record match?
Applicant Name (Manufacturer) :
LANTERNA MEDICAL TECHNOLOGIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Santis Pedicle System is intended for immobilization and stabilization of the spine. The Santis Pedicle System is indicated for posterior, noncervical pedicle fixation as an adjunct to fusion in skeletally mature patients using autograft and/or allograft for the following indications: 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; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
Device Description
The Santis Pedicle Screws Spinal Fixation is comprised of: straight and pre-curved rods, pedicle screw assemblies with both cannulated and non-cannulated screws, compression retaining assemblies, cross connectors and a set screw. Various forms and sizes of these implants are available so that adaptations can be utilized to take into account the unique pathology of individual patients. The Santis system can be implanted either by an open procedure or percutaneous MIS approach, or a combination of both during the same procedure. Components are made of Ti6Al4V ELI, a titanium based alloy, which complies with ASTM F136, or cobalt chrome per ASTM F1537.
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