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FDA 510(k), K233508, iFuse Bedrock Granite® Implant System
FDA 510(k), K233508, iFuse Bedrock Granite® Implant System
Regular price
$49.00 USD
Regular price
Sale price
$49.00 USD
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per
510(K) Number: K233508
Device Name: iFuse Bedrock Granite® Implant System
Manufacturer: Jayasri Prabakaran
Device Classification Name: Sacroiliac Joint Fixation
Regulation Number: OUR
Classification Product Code: KXA
Date Received: 10/31/2023
Decision Date: 01/26/2024
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
Device Name: iFuse Bedrock Granite® Implant System
Manufacturer: Jayasri Prabakaran
Device Classification Name: Sacroiliac Joint Fixation
Regulation Number: OUR
Classification Product Code: KXA
Date Received: 10/31/2023
Decision Date: 01/26/2024
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
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