• 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 Prosthesis, Elbow, Hemi-, Radial, Polymer
510(k) Number K982288
Device Name RADIAL HEAD IMPLANT
Applicant
AVANTA ORTHOPAEDICS, INC.
9369 CARROLL PARK DRIVE, STE.A
SAN DIEGO,  CA  92121
Applicant Contact LOUISE M FOCHT
Correspondent
AVANTA ORTHOPAEDICS, INC.
9369 CARROLL PARK DRIVE, STE.A
SAN DIEGO,  CA  92121
Correspondent Contact LOUISE M FOCHT
Regulation Number888.3170
Classification Product Code
KWI  
Date Received06/30/1998
Decision Date 09/08/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-