Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K143338
Device Classification Name
Plate, Bone
More FDA Info for this Device
510(K) Number
K143338
Device Name
Plate, Bone
Applicant
OSTEOMED L.P.
3885 ARAPAHO RD.
ADDISON, TX 75001 US
Other 510(k) Applications for this Company
Contact
Anita Zacherl
Other 510(k) Applications for this Contact
Regulation Number
872.4760
More FDA Info for this Regulation Number
Classification Product Code
JEY
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/20/2014
Decision Date
04/01/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact