• 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 Spinal Vertebral Body Replacement Device
510(k) Number K990148
Device Name STACKABLE CAGE SYSTEM
Applicant
Depuy Motech Acromed
325 Paramount Dr.
Raynham,  MA  02767
Applicant Contact WILLIAM CHRISTIANSON
Correspondent
Depuy Motech Acromed
325 Paramount Dr.
Raynham,  MA  02767
Correspondent Contact WILLIAM CHRISTIANSON
Regulation Number888.3060
Classification Product Code
MQP  
Date Received01/19/1999
Decision Date 09/03/1999
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
-
-