Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K182878
Device Classification Name
Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
More FDA Info for this Device
510(K) Number
K182878
Device Name
Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
Applicant
Ascension Orthopedics
11101 Metric Blvd.
Austin, TX 78758 US
Other 510(k) Applications for this Company
Contact
Divya Savant
Other 510(k) Applications for this Contact
Regulation Number
888.3110
More FDA Info for this Regulation Number
Classification Product Code
HSN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/15/2018
Decision Date
12/18/2018
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact