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 Bone Cement, Posterior Screw Augmentation
510(k) Number K230774
Device Name PERLA® TL System; TEKTONA® HV US Bone Cement
Applicant
Spineart
3 Chemin De Pré Fleuri
1228 Plan Les Ouates
Geneva,  CH
Applicant Contact Franck Pennesi
Correspondent
Mcra, LLC
803 7th St. Northwest
Third Floor
Washington,  DC  20001
Correspondent Contact Michael Coladonato
Regulation Number888.3027
Classification Product Code
PML  
Subsequent Product Codes
KWP   NKB  
Date Received03/21/2023
Decision Date 06/23/2023
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
-
-