Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K153242
Device Classification Name
Cerclage, Fixation
More FDA Info for this Device
510(K) Number
K153242
Device Name
Cerclage, Fixation
Applicant
FRONTIER MEDICAL DEVICES, INC.
512 FOURTH STREET
GWINN, MI 49841 US
Other 510(k) Applications for this Company
Contact
ALLISON K. ROGERS
Other 510(k) Applications for this Contact
Regulation Number
888.3010
More FDA Info for this Regulation Number
Classification Product Code
JDQ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/09/2015
Decision Date
01/13/2016
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact