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 K980121
Device Name AESCULAP SPINE SYSTEM ADDITIONAL COMPONENTS
Applicant
Aesculap, Inc.
1000 Gateway Blvd.
South San Francisco,  CA  94080
Applicant Contact LIA SPASARO
Correspondent
Aesculap, Inc.
1000 Gateway Blvd.
South San Francisco,  CA  94080
Correspondent Contact LIA SPASARO
Regulation Number888.3050
Classification Product Code
KWP  
Subsequent Product Code
MNH  
Date Received01/14/1998
Decision Date 06/10/1998
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
-
-