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, Semi-Constrained, Metal/Polymer Cemented
510(k) Number K003801
Device Name ANATOMICAL PRESS-FIT HUMERAL STEM
Applicant
Sulzer Orthopedics, Inc.
9900 Spectrum Dr.
Austin,  TX  78717
Applicant Contact MITCHELL A DHORITY
Correspondent
Sulzer Orthopedics, Inc.
9900 Spectrum Dr.
Austin,  TX  78717
Correspondent Contact MITCHELL A DHORITY
Regulation Number888.3660
Classification Product Code
KWS  
Subsequent Product Code
HSD  
Date Received12/08/2000
Decision Date 02/28/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-