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, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained
510(k) Number K080426
Device Name MAESTRO WRIST FRACTURE IMPLANT
Applicant
Biomet Manufacturing Corp
56 E. Bell Dr.,
P.O. Box 587
Warsaw,  IN  46581
Applicant Contact PATRICIA SANDBORN BERES
Correspondent
Biomet Manufacturing Corp
56 E. Bell Dr.,
P.O. Box 587
Warsaw,  IN  46581
Correspondent Contact PATRICIA SANDBORN BERES
Regulation Number888.3800
Classification Product Code
JWJ  
Date Received02/20/2008
Decision Date 07/29/2008
Decision Substantially Equivalent (SESE)
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
-
-