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, fixation, bone
510(k) Number K932352
Device Name ORTHOPEDIC BONE PLATE
Applicant
OSTEOMED CORP.
2753 FREEMAN ST.
FORT WAYNE,  IN  46802
Applicant Contact BILLY DARMAWAN
Correspondent
OSTEOMED CORP.
2753 FREEMAN ST.
FORT WAYNE,  IN  46802
Correspondent Contact BILLY DARMAWAN
Regulation Number888.3030
Classification Product Code
HRS  
Date Received05/14/1993
Decision Date 07/05/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-