FDA 510(k), K091156, TRIMED STERILE PRODUCT

FDA 510(k), K091156, TRIMED STERILE PRODUCT

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510(K) Number: K091156
Device Name: TRIMED STERILE PRODUCT
Manufacturer: KELLI ANDERSON
Device Classification Name: Plate, Fixation, Bone
Regulation Number: HRS
Classification Product Code: KXA
Date Received: 04/21/2009
Decision Date: 07/15/2009
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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