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, Carpal Trapezium
510(k) Number K061451
Device Name ASCENSION, MODELS CMC-400,13,CMC-400-20,CMC-400-30,CMC-400-40
Applicant
Ascension Orthopedics, Inc.
8700 Cameron Rd., Suite 100
Austin,  TX  78754
Applicant Contact GLEN NEALLY
Correspondent
Ascension Orthopedics, Inc.
8700 Cameron Rd., Suite 100
Austin,  TX  78754
Correspondent Contact GLEN NEALLY
Regulation Number888.3770
Classification Product Code
KYI  
Date Received05/25/2006
Decision Date 08/11/2006
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
Recalls CDRH Recalls
-
-