Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K172975
Device Classification Name
Cerclage, Fixation
More FDA Info for this Device
510(K) Number
K172975
Device Name
Cerclage, Fixation
Applicant
Synthes (USA) Products LLC/DePuy Orthopaedics Inc
1301 Goshen Parkway
West Chester, PA 19380 US
Other 510(k) Applications for this Company
Contact
Suchitra Basu
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
09/27/2017
Decision Date
06/21/2018
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