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510(k) Data Aggregation
Device Name
Arthrex FiberTak Suture AnchorManufacturer
Date Cleared
2026-03-20
(29 days)
Product Code
Regulation Number
888.3040Type
SpecialPanel
OrthopedicAge Range
N/A
Reference & Predicate Devices
N/A
Predicate For
N/A
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Device Name
Arthrex Humeral NailsManufacturer
Date Cleared
2026-03-20
(266 days)
Product Code
Regulation Number
888.3020Type
TraditionalPanel
OrthopedicAge Range
N/A
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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Device Name
AutoContour (RADAC V5)Manufacturer
Date Cleared
2026-03-19
(30 days)
Product Code
Regulation Number
892.2050Type
SpecialPanel
RadiologyAge Range
N/A
Reference & Predicate Devices
N/A
Predicate For
N/A
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Device Name
AlignRT Plus (8.0)Manufacturer
Date Cleared
2026-03-18
(180 days)
Product Code
Regulation Number
892.5050Type
TraditionalPanel
RadiologyAge Range
N/A
Reference & Predicate Devices
N/A
Predicate For
N/A
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Manufacturer
Date Cleared
2026-03-18
(5 days)
Product Code
Regulation Number
872.3260Type
TraditionalPanel
DentalAge Range
N/A
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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Device Name
APS Spear Locking PlateManufacturer
Date Cleared
2026-03-17
(90 days)
Product Code
Regulation Number
888.3030Type
TraditionalPanel
OrthopedicAge Range
N/A
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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Manufacturer
Date Cleared
2026-03-16
(98 days)
Product Code
Regulation Number
888.3030Type
TraditionalPanel
OrthopedicAge Range
N/A
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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Device Name
Apollo Quattro (APQ-10M)Manufacturer
Date Cleared
2026-03-13
(165 days)
Product Code
Regulation Number
878.4400Type
TraditionalAge Range
N/A
Reference & Predicate Devices
N/A
Predicate For
N/A
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Device Name
Access anti-HBc IgMManufacturer
Date Cleared
2026-03-13
(86 days)
Product Code
Regulation Number
866.3173Type
TraditionalPanel
MicrobiologyAge Range
N/A
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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Manufacturer
Date Cleared
2026-03-13
(28 days)
Product Code
Regulation Number
870.1250Type
SpecialPanel
CardiovascularAge Range
N/A
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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