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510(k) Data Aggregation
K Number
K990355Device Name
STAINLESS STEEL SOFT SUTURE WIRE
Manufacturer
BREGMA INTERNATIONAL TRADING COMPANY LTD.
Date Cleared
1999-07-08
(153 days)
Product Code
LRN
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
BREGMA INTERNATIONAL TRADING COMPANY LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Stainless Steel Soft Suture Wire is intended for general orthopedic surgery such as Sternulli Closure, nature bones and patella fracture fixation. The device is also intended for soft tissue approximation such as abdominal wound closure and hernia repair.
Device Description
Suture Wire (87 LRN)
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K Number
K990351Device Name
BONE SCREWS
Manufacturer
BREGMA INTERNATIONAL TRADING COMPANY LTD.
Date Cleared
1999-06-01
(116 days)
Product Code
HWC, JDW
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
BREGMA INTERNATIONAL TRADING COMPANY LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Bone screws are used to fix fractured long and short bones. They are also used to fasten bone plates. Bregma International manufactures three kinds of bonc screws, Aach with its own intended use. Cortical bone screws are used to augment compact and hard bones (diaphyseal reglons of the bones). Cancelluus bone screws are used in the epiphyseal and metaphyseal reglons of the bones which are largely soft and spongy. Cannulated bone screws, are used in situations where surgical wire is required to pass through the central axis of the screw, along which a holes has been drilled.
Device Description
Not Found
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K Number
K990353Device Name
STAINLESS STEEL FIXATION PINS
Manufacturer
BREGMA INTERNATIONAL TRADING COMPANY LTD.
Date Cleared
1999-06-01
(116 days)
Product Code
JDW, HWC
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
BREGMA INTERNATIONAL TRADING COMPANY LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Kirschner Wire - ankle fracture fixation femoral shaft fracture hand fracture scaphold fracturc skeletal tractlon wrist fracture patellar fracture
Steinman Pin - ankle arthrodesis tiblotibular syndesmosis fixallorı femoral shaft fracture acromloclavicular Jolnt repair skeletal traction
Device Description
Stainless Stool Fixation Pins
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