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 Intervertebral Body
510(k) Number K943694
Device Name EBI ANTERIOR CERVICAL SPINE SYSTEM
Applicant
Electro-Biology, Inc.
6 Upper Pond Rd.
P.O. Box 345
Parsippany,  NJ  07054
Applicant Contact SHARON A STAROWICZ
Correspondent
Electro-Biology, Inc.
6 Upper Pond Rd.
P.O. Box 345
Parsippany,  NJ  07054
Correspondent Contact SHARON A STAROWICZ
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received07/29/1994
Decision Date 02/08/1995
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-