Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K092464
Device Classification Name
System, Facet Screw Spinal Device
More FDA Info for this Device
510(K) Number
K092464
Device Name
System, Facet Screw Spinal Device
Applicant
SPINEOLOGY, INC.
7200 HUDSON BLVD. N.
SUITE 205
ST. PAUL, MN 55128 US
Other 510(k) Applications for this Company
Contact
Karen Roche
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
MRW
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/11/2009
Decision Date
11/09/2009
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
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