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 suture, nonabsorbable, synthetic, polyethylene
510(k) Number K180191
Device Name SuperBall Meniscal Repair System
Applicant
Arcuro Medical Ltd.
17 Tchelet St.
Misgav,  IL 2017400
Applicant Contact Lee Ranon
Correspondent
Hogan Lovells US LLP
1735 Market Street, Floor 23
Philadelphia,  PA  19103
Correspondent Contact Janice M. Hogan
Regulation Number878.5000
Classification Product Code
GAT  
Date Received01/23/2018
Decision Date 06/05/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-