• 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 fastener, fixation, biodegradable, soft tissue
510(k) Number K192824
Device Name Parcus Knotless AP Suture Anchors
Parcus Medical, LLC
6423 Parkland Dr
sarasota,  FL  34243
Applicant Contact paul vagts
Parcus Medical, LLC
6423 Parkland Dr
sarasota,  FL  34243
Correspondent Contact paul vagts
Regulation Number888.3030
Classification Product Code
Date Received10/02/2019
Decision Date 11/02/2019
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Special
Reviewed by Third Party No
Combination Product No