Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K071053
Device Classification Name
Prosthesis, Hip, Femoral, Resurfacing
More FDA Info for this Device
510(K) Number
K071053
Device Name
Prosthesis, Hip, Femoral, Resurfacing
Applicant
BIOMET, INC.
P.O. BOX 587
WARSAW, IN 46581-0587 US
Other 510(k) Applications for this Company
Contact
BECKY EARL
Other 510(k) Applications for this Contact
Regulation Number
888.3400
More FDA Info for this Regulation Number
Classification Product Code
KXA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/13/2007
Decision Date
06/29/2007
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