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 Screw, Fixation, Bone
510(k) Number K962779
Device Name COMPRESSION SCREW
Applicant
Orthopaedic Biosystems, Ltd.
7320 E. Butherus
Suite 206
Scotsdale,  AZ  85260
Applicant Contact JEFFRY B SKIBA
Correspondent
Orthopaedic Biosystems, Ltd.
7320 E. Butherus
Suite 206
Scotsdale,  AZ  85260
Correspondent Contact JEFFRY B SKIBA
Regulation Number888.3040
Classification Product Code
HWC  
Date Received07/17/1996
Decision Date 08/23/1996
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-