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 K002775
Device Name DISTAL VOLAR RADIUS FRACTURE REPAIR SYSTEM
Applicant
Hand Innovations, Inc.
19526 E. Lake Dr.
Miami,  FL  33015
Applicant Contact AL WEISENBORN
Correspondent
Hand Innovations, Inc.
19526 E. Lake Dr.
Miami,  FL  33015
Correspondent Contact AL WEISENBORN
Regulation Number888.3030
Classification Product Code
HRS  
Date Received09/06/2000
Decision Date 12/05/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-