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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name plate, cranioplasty, preformed, non-alterable
510(K) Number K121102
Model PATIENT-SPECIFIC
Device Name OSTEOSYMBIONICS PEEK CRANIAL IMPLANT
Applicant
OSTEOSYMBIONICS, LLC
p.o. box 560
stillwater,  MN  55082
Contact elaine duncan
Regulation Number882.5330
Classification Product Code
GXN  
Date Received04/11/2012
Decision Date 08/08/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Neurology
Review Advisory Committee Neurology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-