Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K992147
Device Classification Name
Orthosis, Spinal Pedicle Fixation
More FDA Info for this Device
510(K) Number
K992147
Device Name
Orthosis, Spinal Pedicle Fixation
Applicant
ADVANCED SPINE TECHNOLOGY, INC.
3645GRAND AVE., SUITE 304
OAKLAND, CA 94610 US
Other 510(k) Applications for this Company
Contact
GORDON TAO
Other 510(k) Applications for this Contact
Regulation Number
888.3070
More FDA Info for this Regulation Number
Classification Product Code
MNI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/24/1999
Decision Date
02/28/2000
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