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 Retractor
510(k) Number K880151
Device Name HIP, FEMUR AND HUMERUS RETRACTOR
Applicant
Twenty-First Century Orthopedics, Inc.
P.O. Box 308
Vienna,  NJ  07880
Applicant Contact V QUARANTA
Correspondent
Twenty-First Century Orthopedics, Inc.
P.O. Box 308
Vienna,  NJ  07880
Correspondent Contact V QUARANTA
Regulation Number878.4800
Classification Product Code
GAD  
Date Received01/13/1988
Decision Date 02/18/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-