• 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 | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back To Search Results
Device Classification Name screw, fixation, bone
510(k) Number K010554
Device Name MENISCUS ARROW SHEATH #CN1000A; SMARTSCREW ACL SHEATH #SSA2000A
Original Applicant
BIONX IMPLANTS, INC.
hermiankatu 6-8 l
tampere,  FI fin-33720
Original Contact tuija annala
Regulation Number888.3040
Classification Product Code
HWC  
Subsequent Product Code
MAI  
Date Received02/26/2001
Decision Date 05/25/2001
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-