Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
510(k) Number K962238
Device Name SELECT SHOULDER KEELED ALL-POLY GLENOIDS
Applicant
Intermedics Orthopedics
9900 Spectrum Dr.
Austin,  TX  78717
Applicant Contact MITCHELL A DHORITY
Correspondent
Intermedics Orthopedics
9900 Spectrum Dr.
Austin,  TX  78717
Correspondent Contact MITCHELL A DHORITY
Regulation Number888.3650
Classification Product Code
KWT  
Subsequent Product Code
KWS  
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
-
-