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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/polymer, porous uncemented
510(k) Number K121684
Models 162-00-02/03/04/05, 162-01-02/03/04/05
Device Name NOVATION LPI PRIME FEMORAL STEM
Original Applicant
EXACTECH, INC.
2320 n.w. 66th ct.
gainesville,  FL  32653
Original Contact vladislava zaitseva
Regulation Number888.3358
Classification Product Code
LPH  
Subsequent Product Codes
KWY   LZO  
Date Received06/07/2012
Decision Date 10/01/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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