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510(k) Data Aggregation
K Number
K002125Device Name
PINS AND WIRESManufacturer
Date Cleared
2000-10-11
(89 days)
Product Code
Regulation Number
888.3040Type
TraditionalPanel
OrthopedicReference & Predicate Devices
N/A
Why did this record match?
Applicant Name (Manufacturer) :
IMPLANT RESOURCE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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K Number
K970378Device Name
STRYKER 2115 REPLACEMENT BATTERY (2115)Manufacturer
Date Cleared
1997-04-30
(89 days)
Product Code
Regulation Number
878.4820Type
TraditionalPanel
OrthopedicReference & Predicate Devices
N/A
Why did this record match?
Applicant Name (Manufacturer) :
IMPLANT RESOURCE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
Ask a Question
Ask a specific question about this device
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