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 Intervertebral Fusion Device With Bone Graft, Lumbar
510(k) Number K140577
Device Name INNESIS PEEK TL CAGE
Applicant
Bk Meditech, Co., Ltd.
P.O. Box 560
Stillwater,  MN  55082
Applicant Contact ELAINE DUNCAN
Correspondent
Bk Meditech, Co., Ltd.
P.O. Box 560
Stillwater,  MN  55082
Correspondent Contact ELAINE DUNCAN
Regulation Number888.3080
Classification Product Code
MAX  
Date Received03/06/2014
Decision Date 10/01/2014
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
-
-