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 appliance, fixation, spinal intervertebral body
510(k) Number K040261
Device Name REFLEX HYBRID ANTERIOR CERVICAL PLATE SYSTEM
Applicant
STRYKER SPINE
6 PEARL COURT
ALLENDALE,  NJ  07401 -1677
Applicant Contact SIMONA VOIC
Correspondent
STRYKER SPINE
6 PEARL COURT
ALLENDALE,  NJ  07401 -1677
Correspondent Contact SIMONA VOIC
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received02/04/2004
Decision Date 04/16/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-