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, Elbow, Semi-Constrained, Cemented
510(k) Number K222807
Device Name TEMA Elbow system - Line extension
Applicant
Lima Corporate S.P.A.
Via Nazionale 52
San Daniele Del Friuli,  IT 33038
Applicant Contact Marco Tallerico
Correspondent
Lima U.S.A., Inc.
2001 NE Green Oaks Blvd.
Suite 100
Arlington,  TX  76006
Correspondent Contact Kenneth Newman
Regulation Number888.3160
Classification Product Code
JDB  
Subsequent Product Code
JDC  
Date Received09/16/2022
Decision Date 10/26/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-