Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K080075
Device Classification Name
Orthosis, Spinal Pedicle Fixation
More FDA Info for this Device
510(K) Number
K080075
Device Name
Orthosis, Spinal Pedicle Fixation
Applicant
ELITE SURGICAL SUPPLIES (PTY) LTD.
503 COMMERCE PARK DRIVE
SUITE 1
MARIETTA, GA 30060 US
Other 510(k) Applications for this Company
Contact
CHARISE DE BARROS
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
01/11/2008
Decision Date
01/28/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact