Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K051820
Device Classification Name
Injector, Vertebroplasty (Does Not Contain Cement)
More FDA Info for this Device
510(K) Number
K051820
Device Name
Injector, Vertebroplasty (Does Not Contain Cement)
Applicant
ARTHROCARE CORP.
680 VAQUEROS AVE.
SUNNYVALE, CA 94085-3523 US
Other 510(k) Applications for this Company
Contact
VALERIE DEFIESTA-NG
Other 510(k) Applications for this Contact
Regulation Number
888.4200
More FDA Info for this Regulation Number
Classification Product Code
OAR
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/05/2005
Decision Date
09/06/2005
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