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 Bone Cement, Antibiotic
510(k) Number K161273
Device Name StageOne Disposable Cement Spacer Molds for Temporary Knee Prosthesis
Applicant
Biomet, Inc.
56 East Bell Drive
Warsaw,  IN  46581
Applicant Contact Carmen Albany
Correspondent
Biomet, Inc.
56 East Bell Drive
Warsaw,  IN  46581
Correspondent Contact Heidi Busz
Regulation Number888.3027
Classification Product Code
MBB  
Subsequent Product Code
JWH  
Date Received05/05/2016
Decision Date 01/25/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-