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, Calcium Compound
510(k) Number K081227
Device Name PLEXUR M
Applicant
Osteotech, Inc.
51 James Way
Eatontown,  NJ  07724
Applicant Contact CHRIS TALBOT
Correspondent
Osteotech, Inc.
51 James Way
Eatontown,  NJ  07724
Correspondent Contact CHRIS TALBOT
Regulation Number888.3045
Classification Product Code
MQV  
Date Received04/30/2008
Decision Date 07/22/2008
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
-
-