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Found 21 results
510(k) Data Aggregation
K Number
K040685Device Name
Z - SERIES MODULAR TOTAL HIP SYSTEM PLASMA COATED
Manufacturer
OSTEOIMPLANT TECHNOLOGY, INC.
Date Cleared
2005-01-25
(315 days)
Product Code
LWJ, JDI, KWL, KWY, LZO
Regulation Number
888.3360Why did this record match?
Applicant Name (Manufacturer) :
OSTEOIMPLANT TECHNOLOGY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Z™ - Series Modular Total Hip System Plasma Coated is indicated for use in total or partial hip replacements in patients suffering severe pain and disability due to structural hip problems such as rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, traumatic and non-union of femoral fractures. Use of the prosthesis is also indicated in patients with congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis, and failed previous fusion, where bone stock is inadequate for other reconstruction techniques. CP Titanium Plasma Coated Implants are intended for Cement or Press Fit Applications.
Device Description
Not Found
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K Number
K041443Device Name
OTI ALUMINA CERAMIC FEMORAL HEAD SYSTEM
Manufacturer
OSTEOIMPLANT TECHNOLOGY, INC.
Date Cleared
2004-11-16
(168 days)
Product Code
LZO
Regulation Number
888.3353Why did this record match?
Applicant Name (Manufacturer) :
OSTEOIMPLANT TECHNOLOGY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
OTI Alumina Ceramic Femoral Head System is indicated for use in total or partial hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, post traumatic arthritis, collagen disorders, avascular necrosis, traumatic arthritis, congenital hip dysplasia, protrusio acetabuli, slipped Capital Femoral Epiphysis, failed previous fusion, where acetabular reconstruction is not possible, and revision of previously failed hip arthroplasty.
Device Description
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K Number
K040225Device Name
OTI ALUMINA CERAMIC FEMORAL HEAD SYSTEM
Manufacturer
OSTEOIMPLANT TECHNOLOGY, INC.
Date Cleared
2004-05-06
(94 days)
Product Code
KWZ
Regulation Number
888.3310Why did this record match?
Applicant Name (Manufacturer) :
OSTEOIMPLANT TECHNOLOGY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
OTI Alumina Ceramic Femoral Head System is indicated for use in total or partial hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, traumatic and non-union of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis, and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques.
Device Description
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K Number
K032729Device Name
Z-SERIES MODULAR TOTAL HIP SYSTEM
Manufacturer
OSTEOIMPLANT TECHNOLOGY, INC.
Date Cleared
2003-12-03
(91 days)
Product Code
LPH
Regulation Number
888.3358Why did this record match?
Applicant Name (Manufacturer) :
OSTEOIMPLANT TECHNOLOGY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Z™ - Series Modular Total Hip System is indicated for use in total or partial hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, traumatic and non-union of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis, and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques.
Device Description
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K Number
K030608Device Name
OTI BONE CEMENT PLUG
Manufacturer
OSTEOIMPLANT TECHNOLOGY, INC.
Date Cleared
2003-06-12
(106 days)
Product Code
JDK
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
OSTEOIMPLANT TECHNOLOGY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The OTI Bone Cement Plug is intended to allow bone cement pressurization in the intramedullary canal and preventing cement seepage distally. The Bone Plug is placed into the intramedullary canal of the femur at a set distance from the proximal end prior to placement of bone cement and Femoral Prosthesis.
Device Description
OTI Bone Cement Plug - Line extension
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K Number
K022779Device Name
OTI UNICONDULAR INTERPOSITIONAL SPACER
Manufacturer
OSTEOIMPLANT TECHNOLOGY, INC.
Date Cleared
2002-11-20
(90 days)
Product Code
HSH
Regulation Number
888.3590Why did this record match?
Applicant Name (Manufacturer) :
OSTEOIMPLANT TECHNOLOGY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The OTI Unicondular Interpositional Spacer is intended for use in the Osteoarthritic knee, where substantial amounts of articular cartlige have been lost as a result of the disease.
The prostheses will be used in indications for uncemented treatment of the Tibia articulating surfaces (Medial and Lateral) of the following:
Moderate degeneration of the Medial and/or Lateral compartment of the knee (grade II-IV chondromalicia ) and minimal degeneration (grade I-II chondromalacia, no loss of joint space) in the patellofemoral components.
Device Description
OTI Unicondular Interpositional Spacer System
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K Number
K021822Device Name
R120 MODULAR TOTAL HIP SYSTEM
Manufacturer
OSTEOIMPLANT TECHNOLOGY, INC.
Date Cleared
2002-07-23
(49 days)
Product Code
JDI, LHP
Regulation Number
888.3350Why did this record match?
Applicant Name (Manufacturer) :
OSTEOIMPLANT TECHNOLOGY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The R120™ Modular Total Hip System is indicated for use in total or partial hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, traumatic and non-union of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis, and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques. The Total Hip System is intended for use with and without bone cement.
Device Description
Not Found
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K Number
K012762Device Name
MJS POSTERIOR STABILIZED KNEE SYSTEM
Manufacturer
OSTEOIMPLANT TECHNOLOGY, INC.
Date Cleared
2001-12-11
(116 days)
Product Code
HRY
Regulation Number
888.3530Why did this record match?
Applicant Name (Manufacturer) :
OSTEOIMPLANT TECHNOLOGY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MJS Posterior Stabilized Knee System is indicated for use in total knee replacement procedures for patients suffering from:
- Rheumatoid arthritis. ●
- Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose . age, weight, and activity level are compatible with an adequate long-term result.
- Failed osteotomies, unicompartmental replacement, or total knee replacement. .
The Posterior stabilized system is intended for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact and extra joint stability is required.
Device Description
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K Number
K011774Device Name
R120 MODULAR TOTAL HIP SYSTEM
Manufacturer
OSTEOIMPLANT TECHNOLOGY, INC.
Date Cleared
2001-09-05
(90 days)
Product Code
JDI, LPH
Regulation Number
888.3350Why did this record match?
Applicant Name (Manufacturer) :
OSTEOIMPLANT TECHNOLOGY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The R120™ Modular Total Hip System is indicated for use in total or partial hip replacement The X120 - Northering sovere pain and disability due to structural damage in the hip joint from rheumatoid atthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, traumatic and non-union of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis, and disability due to previous fusion, where bone stock is inadequate for other opplysis, that encation a. The Total Hip System is intended for use with and without bone cement.
Device Description
Not Found
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K Number
K003316Device Name
OTI CERAMIC FEMORAL HEAD SYSTEM
Manufacturer
OSTEOIMPLANT TECHNOLOGY, INC.
Date Cleared
2001-01-19
(88 days)
Product Code
LZO
Regulation Number
888.3353Why did this record match?
Applicant Name (Manufacturer) :
OSTEOIMPLANT TECHNOLOGY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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