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 K081608
Device Name PROXIMAL HUMERUS SCAFFOLD FIXATION SYSTEM (PHSFS)
Applicant
TOBY ORTHOPAEDICS, LLC
3773 MATHESON AVENUE
MIAMI,  FL  33133
Applicant Contact AL WEISENBORN
Correspondent
TOBY ORTHOPAEDICS, LLC
3773 MATHESON AVENUE
MIAMI,  FL  33133
Correspondent Contact AL WEISENBORN
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received06/09/2008
Decision Date 12/19/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-