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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 K970706
Device Name INTER-OP POROUS PROTRUSIO SHELL WITH SEALABLE SCREWHOLES
Applicant
SULZER ORTHOPEDICS, INC.
9900 SPECTRUM DR.
AUSTIN,  TX  78717
Applicant Contact SHAVAWN PARDUHN
Correspondent
SULZER ORTHOPEDICS, INC.
9900 SPECTRUM DR.
AUSTIN,  TX  78717
Correspondent Contact SHAVAWN PARDUHN
Regulation Number888.3358
Classification Product Code
LPH  
Subsequent Product Code
LZO  
Date Received02/26/1997
Decision Date 05/22/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
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