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 Fastener, Fixation, Nondegradable, Soft Tissue
510(k) Number K121356
Device Name MICRO/MINI N-PK(H) BONE ANCHOR
Applicant
Anulex Technologies, Inc.
5600 Rowland Rd., Suite 280
Minnetonka,  MN  55343
Applicant Contact RACHEL KENNEDY
Correspondent
Anulex Technologies, Inc.
5600 Rowland Rd., Suite 280
Minnetonka,  MN  55343
Correspondent Contact RACHEL KENNEDY
Regulation Number888.3040
Classification Product Code
MBI  
Date Received05/04/2012
Decision Date 11/09/2012
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
-
-