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510(k) Data Aggregation
K Number
K052237Device Name
SC CERAMIC BALL HEADS
Manufacturer
ORTHOPEDIC ALLIANCE LLC
Date Cleared
2005-09-06
(20 days)
Product Code
LZO
Regulation Number
888.3353Why did this record match?
Applicant Name (Manufacturer) :
ORTHOPEDIC ALLIANCE LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SC Ceramic Ball Heads are indicated for use in the treatment of severely disabled hip joints resulting from painful osteo-,rheumatoid and post-traumatic arthritis, and the late stages of avascular necrosis, and for revision of previous hip surgeries. The SC Femoral Hip Stem is indicated for use with or without bone cement. The SC Acetabular Cup is for use with bone cement only.
Device Description
We added 6 sizes, 28 S, 28 M, 28 L, 32 S, 32 M, and 32 L of ceramic ball heads to the SC Total Hip System, which was cleared for marketing by FDA on 10/15/03 (K031474). These ball heads allow the surgeon a further option to meet the patient's needs.
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K Number
K033826Device Name
ORTHOPEDIC ALLIANCE SPINE SYSTEM
Manufacturer
ORTHOPEDIC ALLIANCE LLC
Date Cleared
2004-07-01
(204 days)
Product Code
MNI
Regulation Number
888.3070Why did this record match?
Applicant Name (Manufacturer) :
ORTHOPEDIC ALLIANCE LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Orthopedic Alliance Spine System is a pedicle screw system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, spinal tumor and failed previous fusion ( pseudarthrosis ).
The Orthopedic Alliance Spine System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis ( grades 3 and 4 ) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine ( L3 to sacrum ) with removal of the implants after the attainment of a solid fusion.
Device Description
The Orthopedic Alliance Spine System is a top-loading multiple component posterior spinal fixation system which consists of fixed and swivel-head pedicle screws, rods, locking cap screws, and a transverse linking mechanism. The screws are available in various lengths and diameters. The swivel-head pedicle screws are assembled at the factory to provide variable axis screw assemblies. The rods are 4mm in diameter and available in various lengths. The locking cap nuts are applied to the screws after the rods are placed to lock them into position. Cross linkage braces are also available to connect from one rod to another in bilateral constructs.
Materials: The devices are manufactured from CP Titanium and Ti6Al-4V ELI Titanium alloy per ASTM and ISO standards.
Function: The Orthopedic Alliance Spine System functions to provide immobilization and stabilization of the spine as an adjunct to fusion in the treatment of chronic instabilities or deformities of the spine.
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K Number
K031474Device Name
SC TOTAL HIP SYSTEM
Manufacturer
ORTHOPEDIC ALLIANCE LLC
Date Cleared
2003-10-15
(159 days)
Product Code
JDI, LWJ
Regulation Number
888.3350Why did this record match?
Applicant Name (Manufacturer) :
ORTHOPEDIC ALLIANCE LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SC Total Hip System is indicated for use in the treatment of severcly disabled hip joints resulting from painful osteo-, rheumatoid and post-traumatic arthritis, and the late stages of avascular necrosis, and for revision of previous hip surgeries.
The SC Femoral Hip Stem is indicated for use with or without bonc cement.
The SC Acetabular Cup is for use with bone cement only.
Device Description
The SC Total Hip System is a total hip system used for the replacement of severely disabled hip joints. It consists of femoral stems, modular femoral heads and acetabular components. The femoral stems are straight, non-porous collarless designs in standard and lateralized configurations. Revision lengths are also available. The acctabular components are UHMWPE, in various diameters, with various offset options.
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