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 Orthosis, Spinal Pedicle Fixation
510(k) Number K032394
Device Name STRYKER SPINE OASYS SYSTEM
Applicant
Howmedica Osteonics Corp.
59 Route 17 S.
Allendale,  NJ  07401 -1677
Applicant Contact KAREN ARIEMMA
Correspondent
Howmedica Osteonics Corp.
59 Route 17 S.
Allendale,  NJ  07401 -1677
Correspondent Contact KAREN ARIEMMA
Regulation Number888.3070
Classification Product Code
MNI  
Subsequent Product Code
KWP  
Date Received08/04/2003
Decision Date 02/20/2004
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
-
-