Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K132366
Device Classification Name
Appliance, Fixation, Spinal Intervertebral Body
More FDA Info for this Device
510(K) Number
K132366
Device Name
Appliance, Fixation, Spinal Intervertebral Body
Applicant
ACCEL SPINE
14901 QUORUM DR. STE. 125
DALLAS, TX 75254 US
Other 510(k) Applications for this Company
Contact
AEKTA PATEL
Other 510(k) Applications for this Contact
Regulation Number
888.3060
More FDA Info for this Regulation Number
Classification Product Code
KWQ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/30/2013
Decision Date
09/03/2013
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