Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K081163
Device Classification Name
Bone Cement, Antibiotic
More FDA Info for this Device
510(K) Number
K081163
Device Name
Bone Cement, Antibiotic
Applicant
DEPUY ORTHOPAEDICS, INC.
700 ORTHOPAEDIC DRIVE
WARSAW, IN 46581-0988 US
Other 510(k) Applications for this Company
Contact
SUZANA OTANO
Other 510(k) Applications for this Contact
Regulation Number
888.3027
More FDA Info for this Regulation Number
Classification Product Code
MBB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/24/2008
Decision Date
05/14/2008
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