Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K162726
Device Classification Name
More FDA Info for this Device
510(K) Number
K162726
Device Name
Exactech« Equinoxe« Preserve Stem
Applicant
EXACTECH INC
2320 NW 66TH COURT
GAINESVILLE, FL 32653 US
Other 510(k) Applications for this Company
Contact
Thomas McNamara
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
PHX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/29/2016
Decision Date
02/01/2017
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