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 K111379
Device Name EQUINOXE UHMWPE 12* POSTERIOR AUGMENT PEGGED GLENOID, SMALL / MEDIUM / LARGE / EXTRA-LARGE, LEFT / RIGHT
Applicant
Exactech, Inc.
2320 NW 66th Ct.
Gainesville,  FL  32653
Applicant Contact GRAHAM L CUTHBERT
Correspondent
Exactech, Inc.
2320 NW 66th Ct.
Gainesville,  FL  32653
Correspondent Contact GRAHAM L CUTHBERT
Regulation Number888.3660
Classification Product Code
KWS  
Date Received05/17/2011
Decision Date 06/08/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-