FDA 510(k), K003016, PRO-FEMUR R

FDA 510(k), K003016, PRO-FEMUR R

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510(K) Number: K003016
Device Name: PRO-FEMUR R
Manufacturer: WRIGHT MEDICAL TECHNOLOGY, INC.
Device Classification Name: prosthesis, hip, semi-constrained, metal/polymer, uncemented
Regulation Number: 888.3360
Classification Product Code: LWJ
Date Received: 09/27/2000
Decision Date: 12/13/2000
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. IMPORTANT: The FDA FOIA office operations are currently suspended. We are happy to make the request but do not know when we will receive a response. Learn more about Fast-Track Requests here.

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