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 Suture, Nonabsorbable, Synthetic, Polyethylene
510(k) Number K053339
Device Name ALLOFIX ANCHOR
Applicant
MUSCULOSKELETAL TRANSPLANT FOUNDATION
125 MAY STREET
EDISON,  NJ  08837
Applicant Contact NANCY L BENNEWITZ
Correspondent
MUSCULOSKELETAL TRANSPLANT FOUNDATION
125 MAY STREET
EDISON,  NJ  08837
Correspondent Contact NANCY L BENNEWITZ
Regulation Number878.5000
Classification Product Code
GAT  
Subsequent Product Codes
HWC   JDW  
Date Received12/01/2005
Decision Date 03/16/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-