Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K151983
Device Classification Name
Cerclage, Fixation
More FDA Info for this Device
510(K) Number
K151983
Device Name
Cerclage, Fixation
Applicant
KLS MARTIN L.P.
11201 SAINT JOHNS INDUSTRIAL
PARKWAY SOUTH
JACKSONVILLE, FL 32246 US
Other 510(k) Applications for this Company
Contact
JENNIFER DAMATO
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
07/17/2015
Decision Date
04/06/2016
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