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 prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate
510(k) Number K153131
Device Name Logical C-Series Acetabular Shell, Logical Constrained Liner, Logical Constrained Liner Collar, Logical 20° Hooded Acetabular Liner
Applicant
SIGNATURE ORTHOPAEDICS PTY LTD.
7 SIRIUS ROAD
LANE COVE,  AU 2066
Applicant Contact DECLAN BRAZIL
Correspondent
SIGNATURE ORTHOPAEDICS PTY LTD.
7 SIRIUS ROAD
LANE COVE,  AU 2066
Correspondent Contact DECLAN BRAZIL
Regulation Number888.3353
Classification Product Code
MEH  
Subsequent Product Codes
KWZ   LPH  
Date Received10/30/2015
Decision Date 06/03/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-