• 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 + additive, cemented
510(k) Number K121183
Device Name COMPREHENSIVE REVERSE SHOULDER - E1 POLYETHYLENE CLAIMS
Applicant
BIOMET CORPORATION
56 east bell drive
warsaw,  IN  46580
Applicant Contact patricia sandborn beres
Correspondent
BIOMET CORPORATION
56 east bell drive
warsaw,  IN  46580
Correspondent Contact patricia sandborn beres
Regulation Number888.3660
Classification Product Code
PAO  
Subsequent Product Code
KWS  
Date Received04/18/2012
Decision Date 07/26/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-