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 Staple, Fixation, Bone
510(k) Number K133270
Device Name SPEED ARC
Applicant
Biomedical Enterprises, Inc.
14785 Omicron Dr., Suite 205
San Antonio,  TX  78245
Applicant Contact JOE SOWARD
Correspondent
Biomedical Enterprises, Inc.
14785 Omicron Dr., Suite 205
San Antonio,  TX  78245
Correspondent Contact JOE SOWARD
Regulation Number888.3030
Classification Product Code
JDR  
Date Received10/23/2013
Decision Date 04/17/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-