Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K140066
Device Classification Name
Intervertebral Fusion Device With Bone Graft, Cervical
More FDA Info for this Device
510(K) Number
K140066
Device Name
Intervertebral Fusion Device With Bone Graft, Cervical
Applicant
PINNACLE SPINE GROUP, LLC
1601 Elm St Ste 1930
Dallas, TX 75201 US
Other 510(k) Applications for this Company
Contact
Rebecca K Pine
Other 510(k) Applications for this Contact
Regulation Number
888.3080
More FDA Info for this Regulation Number
Classification Product Code
ODP
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/10/2014
Decision Date
05/05/2014
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