Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K113477
Device Classification Name
Cement, Bone, Vertebroplasty
More FDA Info for this Device
510(K) Number
K113477
Device Name
Cement, Bone, Vertebroplasty
Applicant
STRYKER INSTRUMENTS, INSTRUMENTS DIV.
4100 EAST MILHAM AVE.
KALAMAZOO, MI 49001 US
Other 510(k) Applications for this Company
Contact
CHRISTINA MCKEE
Other 510(k) Applications for this Contact
Regulation Number
888.3027
More FDA Info for this Regulation Number
Classification Product Code
NDN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/23/2011
Decision Date
01/06/2012
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