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 reamer
510(k) Number K111437
Device Name SYNTHES RIA SYSTEM (EXPANDED INDICATIONS)
Applicant
SYNTHES (USA) PRODUCTS LLC
1301 GOSHEN PKWY.
WEST CHESTER,  PA  19380
Applicant Contact ANGELA F LASSANDRO
Correspondent
SYNTHES (USA) PRODUCTS LLC
1301 GOSHEN PKWY.
WEST CHESTER,  PA  19380
Correspondent Contact ANGELA F LASSANDRO
Regulation Number888.4540
Classification Product Code
HTO  
Subsequent Product Code
HRX  
Date Received05/24/2011
Decision Date 08/10/2011
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
-
-