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 interlaminal
510(k) Number K121877
Device Name GIBRALT OCCIPITAL PLATE SCREWS, SET SCREW, GIBRALT OCCIPITAL SYSTEM ARTICULATING ROD, GIBRALT OCCIPITAL PLATES
Applicant
EXACTECH, INC.
2320 N.W. 66TH CT.
GAINESVILLE,  FL  32653
Applicant Contact VLADISLAVA ZAITSEVA
Correspondent
EXACTECH, INC.
2320 N.W. 66TH CT.
GAINESVILLE,  FL  32653
Correspondent Contact VLADISLAVA ZAITSEVA
Regulation Number888.3050
Classification Product Code
KWP  
Date Received06/28/2012
Decision Date 02/12/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-