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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
510(k) Number K962244
Device Name SELECT SHOULDER PEGGED ALL-POLY GLENOID
Applicant
Intermedics Orthopedics
9900 Spectrum Dr.
Austin,  TX  78717
Applicant Contact MITCHEL A DHORITY
Correspondent
Intermedics Orthopedics
9900 Spectrum Dr.
Austin,  TX  78717
Correspondent Contact MITCHEL A DHORITY
Regulation Number888.3650
Classification Product Code
KWT  
Date Received06/11/1996
Decision Date 08/09/1996
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
Predetermined Change
Control Plan Authorized		 No
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