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, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer
510(k) Number K212941
Device Name Porous Patella
Applicant
Encore Medical, L.P. dba DJO Surgical
9800 Metric Boulevard
Austin,  TX  78758
Applicant Contact Michael A Siano
Correspondent
Encore Medical, L.P. dba DJO Surgical
9800 Metric Boulevard
Austin,  TX  78758
Correspondent Contact Michael A Siano
Regulation Number888.3565
Classification Product Code
MBH  
Subsequent Product Code
JWH  
Date Received09/15/2021
Decision Date 01/20/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-