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Found 14 results
510(k) Data Aggregation
K Number
K990436Device Name
ULTIMAX TROCHANTERIC INTRAMEDULLARY ROD SYSTEM
Manufacturer
BIODYNAMIC TECHNOLOGIES, INC.
Date Cleared
1999-03-31
(48 days)
Product Code
HSB
Regulation Number
888.3020Why did this record match?
Applicant Name (Manufacturer) :
BIODYNAMIC TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ULTiMAX™ brand Trochanteric Intramedullary Rod System is indicated for single use to stabilize intertrochanteric and subtrochanteric fractures of the proximal femur.
Device Description
ULTiMAX™ Trochanteric Intramedullary Rod System II
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K Number
K990481Device Name
ULTIMAX DISTAL RADIAL (VOLAR) LOCKING PLATE SYSTEM
Manufacturer
BIODYNAMIC TECHNOLOGIES, INC.
Date Cleared
1999-03-17
(29 days)
Product Code
HRS
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
BIODYNAMIC TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ULTiMAX™ brand Distal Radial (Volar) Locking Plate System is indicated for single use to stabilize distal fractures of the radius.
Device Description
ULTIMAX™ Distal Radial (Volar) Locking Plate System
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K Number
K990513Device Name
ULTIMAX CORTICAL BONE SCREWS
Manufacturer
BIODYNAMIC TECHNOLOGIES, INC.
Date Cleared
1999-03-17
(27 days)
Product Code
HWC
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
BIODYNAMIC TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ULTiMAX™ brand Cortical Bone Screws are indicated for single use for osteotomy fixation, interfragmentary fixation, and for stabilizing fractures in metaphyseal and diaphyseal bone in long bones. Uses include arthrodesis of joints; stabilizing fractures of the medial malleolus and distal tibia; patella fractures; metatarsal fractures and fractures of the calcaneus and other bones in the foot; fractures of bones in the hand; proximal, distal and intercondylar fractures of the humerus; use with the BTI ULTiMAX™ Humeral Intramedullary Rod System.
Device Description
Not Found
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K Number
K981230Device Name
ULTIMAX DISTAL FEMORAL INTRAMEDULLARY ROD SYSTEM
Manufacturer
BIODYNAMIC TECHNOLOGIES, INC.
Date Cleared
1998-06-01
(59 days)
Product Code
HSB
Regulation Number
888.3020Why did this record match?
Applicant Name (Manufacturer) :
BIODYNAMIC TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ULTiMAX™ brand Distal Femoral Intramedullary Rod System is indicated for single use to stabilize distal femoral fractures, including supracondylar fractures, severely comminuted supracondylar fractures with difficult intra-articular extension, fractures that require stabilization of the femoral condylar segment, distal fractures in osteoporotic bone, pathologic fractures, pseudoarthrosis, malunions and failed distal femoral osteosynthesis.
Device Description
ULTiMAX™ Distal Femoral Intramedullary Rod System
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K Number
K980102Device Name
BTI HUMERAL INTRAMEDULLARY ROD SYSTEM
Manufacturer
BIODYNAMIC TECHNOLOGIES, INC.
Date Cleared
1998-04-03
(81 days)
Product Code
HSB
Regulation Number
888.3020Why did this record match?
Applicant Name (Manufacturer) :
BIODYNAMIC TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The BT™ Humeral Intramedullary Rod device is indicated for fractures of the humerus.
Device Description
BTI™ Humeral Intramedullary Rod System
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K Number
K974756Device Name
BTI LARGE (7.0MM) CANNULATED TRANSFIXING SCREWS
Manufacturer
BIODYNAMIC TECHNOLOGIES, INC.
Date Cleared
1998-03-12
(83 days)
Product Code
HWC
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
BIODYNAMIC TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The BTI™ brand Large (7.0 mm) Cannulated Transfixing Screw is indicated for single use with the BTI brand Proximal Humeral Intramedullary Rod, the BTI brand Mid-Shaft Humeral Intramedullary Rod and the BTI brand Tod, the Britishedullary Rod Systems to stablifize fractures.
Device Description
Not Found
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K Number
K972403Device Name
BTI CORTICAL BONE SCREWS
Manufacturer
BIODYNAMIC TECHNOLOGIES, INC.
Date Cleared
1997-08-29
(64 days)
Product Code
HWC
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
BIODYNAMIC TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The BTI™ brand Cortical Bone Screws are indicated for single use for osteotomy fixation, interfragmentary fixation, and for stabilizing fractures in metaphyseal and diaphyseal bone in long bones. Uses include arthrodesis of joints; stabilizing fractures of the medial malleolus and distal tibia; patella fractures; metatarsal fractures and fractures of the calcaneus and other bones in the foot; fractures of bones in the hand; proximal, distal and intercondylar fractures of the humerus; use with the BTI Compression Hip Screw System, BTI Humeral Intramedullary Rod Systems, and the BTI Distal Femoral Intramedullary Rod System.
Device Description
Not Found
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K Number
K970897Device Name
BTI DISTAL FEMORAL INTRAMEDULLARY ROD SYSTEM
Manufacturer
BIODYNAMIC TECHNOLOGIES, INC.
Date Cleared
1997-04-21
(41 days)
Product Code
HSB
Regulation Number
888.3020Why did this record match?
Applicant Name (Manufacturer) :
BIODYNAMIC TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K962706Device Name
EZ-FIX CANNULATED SCREW SYSTEM
Manufacturer
BIODYNAMIC TECHNOLOGIES, INC.
Date Cleared
1996-11-13
(124 days)
Product Code
HWC
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
BIODYNAMIC TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
indicated for single use to stabilize intracapsular, certain cervical and subcapital fractures of the femur; fractures of the distal femur and proximal tible: pelvis and acetabular fractures and certain fractures of the shoulder and elbow. They are contraindicated for attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, lumbar spine.
Device Description
The EZ-Fix™ Cannulated Screws are fabricated from titanium allov (Ti-BAL-4V ELI). They are tested per ASTM standards and have a thread diameter and length of 7.3 mm and 20 mm respectively and a shaft diameter of 5.3 mm. They accept a 3.2 mm guide pin through the 3.45 mm cannulation. They are self reaming and tapping and have reverse cutting flutes. The EZ-Fix™ Cannulated Screws are available in 35 mm to 125 mm lengths are supplied non-sterile.
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K Number
K962987Device Name
EZ-FIX SMALL CANNULATED SCREW SYSTEM
Manufacturer
BIODYNAMIC TECHNOLOGIES, INC.
Date Cleared
1996-11-04
(95 days)
Product Code
HWC
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
BIODYNAMIC TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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