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, Bone
510(k) Number K010351
Device Name INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM
Applicant
Inion , Ltd.
3 Sorinkatu
Tampere,  FI 33100
Applicant Contact HANNA MARTTILA
Correspondent
Inion , Ltd.
3 Sorinkatu
Tampere,  FI 33100
Correspondent Contact HANNA MARTTILA
Regulation Number872.4760
Classification Product Code
JEY  
Date Received02/06/2001
Decision Date 03/15/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-