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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 K980020
Device Name ACTIVELOCK MODULAR FEMORAL HIP SYSTEM
Applicant
METAGEN, L.L.C.
4329 GRAYDON RD.
san diego,  CA  92130
Applicant Contact floyd g larson
Correspondent
METAGEN, L.L.C.
4329 GRAYDON RD.
san diego,  CA  92130
Correspondent Contact floyd g larson
Regulation Number888.3358
Classification Product Code
LPH  
Subsequent Product Codes
JDI   MEH  
Date Received01/05/1998
Decision Date 04/03/1998
Decision substantially equivalent for some indications (SN)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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