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 Appliance, Fixation, Spinal Interlaminal
510(k) Number K010681
Device Name SUMMIT OCCIPITO-CERVICO-THORACIC (OCT) SPINAL SYSTEM
Applicant
Depuyacromed
325 Paramount Dr.
Raynham,  MA  02767
Applicant Contact FRANK MAAS
Correspondent
Depuyacromed
325 Paramount Dr.
Raynham,  MA  02767
Correspondent Contact FRANK MAAS
Regulation Number888.3050
Classification Product Code
KWP  
Subsequent Product Code
MNI  
Date Received03/07/2001
Decision Date 07/18/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-