Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K161426
Device Classification Name
Staple, Fixation, Bone
More FDA Info for this Device
510(K) Number
K161426
Device Name
Staple, Fixation, Bone
Applicant
IN2BONESUSA, LLC
6060 POPLAR AVE, SUITE 380
MEMPHIS, TN 38119 US
Other 510(k) Applications for this Company
Contact
JOE CLIFT
Other 510(k) Applications for this Contact
Regulation Number
888.3030
More FDA Info for this Regulation Number
Classification Product Code
JDR
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/23/2016
Decision Date
10/24/2016
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