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 plate, bone
510(k) Number K000594
Device Name LOCKING SCREW MANDIBULAR RECONSTRUCTION PLATE
Applicant
STRYKER LEIBINGER
4100 EAST MILHAM AVE.
KALAMAZOO,  MI  49001
Applicant Contact ROBIN L ROWE
Correspondent
STRYKER LEIBINGER
4100 EAST MILHAM AVE.
KALAMAZOO,  MI  49001
Correspondent Contact ROBIN L ROWE
Regulation Number872.4760
Classification Product Code
JEY  
Date Received02/22/2000
Decision Date 12/08/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-