• 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 K100361
Device Name NANOSS BONE VOID FILLER
Applicant
PIONEER SURGICAL TECHNOLOGY
11234 EL CAMINO REAL
SUITE 200
san diego,  CA  92130
Applicant Contact david j collette, md
Correspondent
PIONEER SURGICAL TECHNOLOGY
11234 EL CAMINO REAL
SUITE 200
san diego,  CA  92130
Correspondent Contact david j collette, md
Regulation Number888.3045
Classification Product Code
MQV  
Date Received02/12/2010
Decision Date 04/22/2010
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Special
Reviewed by Third Party No
Combination Product Yes
-
-