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 Prosthesis, Hip, Cement Restrictor
510(k) Number K895378
Device Name PROXIMAL CEMENT SPACER
Applicant
OSTEONICS RECONSTRUCTIVE PRODUCTS DIV.
59 ROUTE 17
ALLENDALE,  NJ  07401
Applicant Contact PAT KRAMER
Correspondent
OSTEONICS RECONSTRUCTIVE PRODUCTS DIV.
59 ROUTE 17
ALLENDALE,  NJ  07401
Correspondent Contact PAT KRAMER
Regulation Number878.3300
Classification Product Code
JDK  
Date Received08/30/1989
Decision Date 11/22/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-