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 K161351
Device Name NanoBone SBX Putty
Applicant
Artoss GmbH
Friedrich-Barnewitz-Str. 3
Rostock,  DE 18119
Applicant Contact Walter Gerike
Correspondent
Artoss GmbH
Friedrich-Barnewitz-Str. 3
Rostock,  DE 18119
Correspondent Contact Walter Gerike
Regulation Number888.3045
Classification Product Code
MQV  
Date Received05/16/2016
Decision Date 10/26/2016
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
-
-