Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K050138
Device Classification Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
More FDA Info for this Device
510(K) Number
K050138
Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Applicant
HOWMEDICA OSTEONICS CORP.
325 Corporate Drive
Mahwah, NJ 07430 US
Other 510(k) Applications for this Company
Contact
KAREN ARIEMMA
Other 510(k) Applications for this Contact
Regulation Number
888.3350
More FDA Info for this Regulation Number
Classification Product Code
JDI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/21/2005
Decision Date
03/21/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact