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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
510(k) Number K902332
Device Name HALL MODULAR ACETABULAR REAMER SYSTEM
Applicant
Zimmer, Inc.
Hall Surgical Division
1170 Mark Ave.
Carpinteria,  CA  93013
Applicant Contact DAVID WELLINGTON
Correspondent
Zimmer, Inc.
Hall Surgical Division
1170 Mark Ave.
Carpinteria,  CA  93013
Correspondent Contact DAVID WELLINGTON
Regulation Number878.4820
Classification Product Code
HWE  
Date Received05/24/1990
Decision Date 06/25/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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