• 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 K993166
Device Name STRYKER BIOABSORBABLE INTERFERENCE SCREW SYSTEM
Original Applicant
Stryker Endoscopy
2590 walsh ave.
santa clara,  CA  95051 -4085
Original Contact todd miller
Regulation Number888.3040
Classification Product Code
HWC  
Subsequent Product Code
MAI  
Date Received09/22/1999
Decision Date 08/04/2000
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-