Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K111799
Device Classification Name
Screw, Fixation, Bone
More FDA Info for this Device
510(K) Number
K111799
Device Name
Screw, Fixation, Bone
Applicant
ASCENSION ORTHOPEDIC
8700 CAMERON RD., STE. 100
Austin, TX 78754 US
Other 510(k) Applications for this Company
Contact
BRADLEY W STRASSER
Other 510(k) Applications for this Contact
Regulation Number
888.3040
More FDA Info for this Regulation Number
Classification Product Code
HWC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/27/2011
Decision Date
08/19/2011
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