FDA 510(k), K113318, ACUTE INNOVATIONS MODULAR RIBLOC SYSTEM

FDA 510(k), K113318, ACUTE INNOVATIONS MODULAR RIBLOC SYSTEM

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510(K) Number: K113318
Device Name: ACUTE INNOVATIONS MODULAR RIBLOC SYSTEM
Manufacturer: MARIAH KNIGHT
Device Classification Name: Plate, Fixation, Bone
Regulation Number: HRS
Classification Product Code: KXA
Date Received: 11/10/2011
Decision Date: 01/12/2012
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

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