• 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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name mesh, surgical, absorbable, orthopaedics, reinforcement of tendon
510(k) Number K121216
Model STR1020-23LL
Device Name STR GRAFT
Original Applicant
SOFT TISSUE REGENERATION, INC.
815 iris lane
vero beach,  FL  32963
Original Contact robert a poggie
Regulation Number878.3300
Classification Product Code
OWW  
Subsequent Product Code
OWT  
Date Received04/23/2012
Decision Date 11/21/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-