Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K071031
Device Classification Name
Spinal Vertebral Body Replacement Device
More FDA Info for this Device
510(K) Number
K071031
Device Name
Spinal Vertebral Body Replacement Device
Applicant
THEKEN SPINE LLC
283 E WATERLOO RD.
AKRON, OH 44319 US
Other 510(k) Applications for this Company
Contact
DALE DAVISON
Other 510(k) Applications for this Contact
Regulation Number
888.3060
More FDA Info for this Regulation Number
Classification Product Code
MQP
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/11/2007
Decision Date
07/30/2007
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