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 Arthroscope
510(k) Number K103231
Device Name KYPHON INFLATION SYRINGE
Applicant
Medtronic Spine, LLC
1221 Crossman Ave.
Sunnyvale,  CA  94089
Applicant Contact HETAL JAWAHAR THAKKER
Correspondent
Medtronic Spine, LLC
1221 Crossman Ave.
Sunnyvale,  CA  94089
Correspondent Contact HETAL JAWAHAR THAKKER
Regulation Number888.1100
Classification Product Code
HRX  
Subsequent Product Code
HXG  
Date Received11/01/2010
Decision Date 01/24/2011
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
-
-