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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name prosthesis, hip, semi-constrained (metal uncemented acetabular component)
510(k) Number K063614
Device Name ALTRA FX HIP SYSTEM
Applicant
BIOMET MANUFACTURING CORP.
PO BOX 587
warsaw,  IN  46581 -0587
Applicant Contact becky earl
Correspondent
BIOMET MANUFACTURING CORP.
PO BOX 587
warsaw,  IN  46581 -0587
Correspondent Contact becky earl
  View current 510(K) holder
Current 510(k) Holder *
Zimmer Biomet
56 East Bell Dr.
PO Box 587
warsaw,  IN  46582
Regulation Number888.3330
Classification Product Code
KWA  
Subsequent Product Codes
JDI   JDL   KWL   KWY   KWZ  
LPH   LWJ   LZO   MAY   MEH  
Date Received12/05/2006
Decision Date 02/20/2007
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No

 
* Reported through Establishment Registration and Device Listing
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