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 K153057
FOIA Releasable 510(k) K153057
Device Name FitRite™ Total Hip Arthroplasty System
Applicant
Excera Orthopedics, Inc.
1188 Centre St.
Newton,  MA  02459
Applicant Contact SCOTT COLERIDGE
Correspondent
Orchid Design
4600 E Shelby Dr.
Memphis,  TN  38118
Correspondent Contact KELLEN HILLS
Regulation Number888.3350
Classification Product Code
JDI  
Date Received10/21/2015
Decision Date 06/23/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-