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, Metal/Polymer, Cemented
510(k) Number K955137
Device Name IM C-MENT ACETABULAR CAP
Applicant
Implant Ideas, LLC
4036 Hagadorn Rd.
Suite B
Okemos,  MI  48864
Applicant Contact BRENDA SPARKS
Correspondent
Implant Ideas, LLC
4036 Hagadorn Rd.
Suite B
Okemos,  MI  48864
Correspondent Contact BRENDA SPARKS
Regulation Number888.3350
Classification Product Code
JDI  
Date Received11/13/1995
Decision Date 10/10/1996
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
-
-