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 K873251
Device Name OMNIFIT BONE SCREW
Applicant
OSTEONICS CORP.
59 ROUTE 17
ALLENDALE,  NJ  07401 -1677
Applicant Contact DENNIS H CRANE
Correspondent
OSTEONICS CORP.
59 ROUTE 17
ALLENDALE,  NJ  07401 -1677
Correspondent Contact DENNIS H CRANE
Regulation Number888.3040
Classification Product Code
HWC  
Date Received08/17/1987
Decision Date 09/18/1987
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-