FDA 510(k), K100858, LIMA-LIO SMR SHOULDER SYSTEM - HUMERAL STEMS, LIMA-LIO SMR SHOULDER SYSTEM - HUMERAL BODIES,

FDA 510(k), K100858, LIMA-LIO SMR SHOULDER SYSTEM - HUMERAL STEMS, LIMA-LIO SMR SHOULDER SYSTEM - HUMERAL BODIES,

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510(K) Number: K100858
Device Name: LIMA-LIO SMR SHOULDER SYSTEM - HUMERAL STEMS, LIMA-LIO SMR SHOULDER SYSTEM - HUMERAL BODIES,
Manufacturer: LIMA-LTO S.P.A.
Device Classification Name: prosthesis, shoulder, non-constrained, metal/polymer cemented
Regulation Number: 888.3650
Classification Product Code: KWT
Date Received: 03/26/2010
Decision Date: 12/10/2010
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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