FDA 510(k) Application Details - DEN230012

Device Classification Name

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510(K) Number DEN230012
Device Name Ruthless Spine RJB
Applicant Ruthless, LLC dba Ruthless Spine
1438 Arrow Highway Ste F/G
Irwindale, CA 91706 US
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Contact Renita Howard
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Regulation Number

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Classification Product Code QWL
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Date Received 02/16/2023
Decision Date 07/14/2023
Decision DENG -
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status
Type Direct
Reviewed By Third Party N
Expedited Review



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