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 Orthopedic Stereotaxic Instrument
510(k) Number K220104
Device Name Knee+
Applicant
Pixee Medical
18 rue Alain Savary
Besancon,  FR 25000
Applicant Contact Lucie Pecheur
Correspondent
Pixee Medical
18 rue Alain Savary
Besancon,  FR 25000
Correspondent Contact Lucie Pecheur
Regulation Number882.4560
Classification Product Code
OLO  
Date Received01/12/2022
Decision Date 09/01/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-