Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K171473
Device Classification Name
Staple, Fixation, Bone
More FDA Info for this Device
510(K) Number
K171473
Device Name
Staple, Fixation, Bone
Applicant
Dallen Medical, Inc.
1046 Calle Recodo, Suite G
San Clemente, CA 92673 US
Other 510(k) Applications for this Company
Contact
Al Memmolo
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
05/19/2017
Decision Date
11/07/2017
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