FDA 510(k), K122538, ACUMED PELVIC BONE PLATE SYSTEM

FDA 510(k), K122538, ACUMED PELVIC BONE PLATE SYSTEM

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510(K) Number: K122538
Device Name: ACUMED PELVIC BONE PLATE SYSTEM
Manufacturer: ACUMED LLC
Device Classification Name: plate, fixation, bone
Regulation Number: 888.3030
Classification Product Code: HRS
Date Received: 08/21/2012
Decision Date: 11/19/2012
Regulation Medical Specialty: Orthopedic
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.

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