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 Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)
510(k) Number K091193
Device Name ACCELL EVO3C
Applicant
Isotis Orthobiologics, Inc.
2 Goodyear, Suite A
Irvine,  CA  92618
Applicant Contact CARROLL COUNCILMAN
Correspondent
Isotis Orthobiologics, Inc.
2 Goodyear, Suite A
Irvine,  CA  92618
Correspondent Contact CARROLL COUNCILMAN
Regulation Number888.3045
Classification Product Code
MBP  
Subsequent Product Code
MQV  
Date Received04/23/2009
Decision Date 08/10/2009
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
-
-