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 cranial distraction system
510(k) Number K121304
Device Name OSTEOMED CRANIAL DISTRACTION SYSTEM
Applicant
OSTEOMED
3885 Arapaho Rd
ADDISON,  TX  75001
Applicant Contact PIEDAD PENA
Correspondent
OSTEOMED
3885 Arapaho Rd
ADDISON,  TX  75001
Correspondent Contact PIEDAD PENA
Regulation Number882.5330
Classification Product Code
PBJ  
Date Received05/01/2012
Decision Date 08/22/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-