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Found 4 results
510(k) Data Aggregation
K Number
K011504Device Name
BAUMER LOCKING NAIL
Manufacturer
BAUMER S.A.
Date Cleared
2001-08-14
(90 days)
Product Code
JDS, HSB
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
BAUMER S.A.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Intramedullary nails are anatomic implants specially developed for osteosynthesis. Their objective is to stabilize and fix a fracture through intramedullary blocking. The "Baumer Locking Nail" is indicated to intramedullary fixation for fractures of the tibia (Tibial Locking Nail) and femur (Femoral Locking Nail). The device is for single use; it's should never be reused.
Device Description
Intramedullary nails are anatomic implants specially developed for osteosynthesis.
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K Number
K003975Device Name
BAUMER CEMENTED HIP PROSTHESIS
Manufacturer
BAUMER S.A.
Date Cleared
2001-03-19
(87 days)
Product Code
JDI
Regulation Number
888.3350Why did this record match?
Applicant Name (Manufacturer) :
BAUMER S.A.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K003976Device Name
BAUMER MULLER HIP PROSTHESIS
Manufacturer
BAUMER S.A.
Date Cleared
2001-03-19
(87 days)
Product Code
JDI
Regulation Number
888.3350Why did this record match?
Applicant Name (Manufacturer) :
BAUMER S.A.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K001571Device Name
BAUMER FEMORAL HEAD
Manufacturer
BAUMER S.A.
Date Cleared
2000-08-04
(74 days)
Product Code
JDI
Regulation Number
888.3350Why did this record match?
Applicant Name (Manufacturer) :
BAUMER S.A.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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