Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K023564
Device Classification Name
Cerclage, Fixation
More FDA Info for this Device
510(K) Number
K023564
Device Name
Cerclage, Fixation
Applicant
OSSEUS, LLC
34 WOODLANE RD.
LAWRENCEVILLE, NJ 08648 US
Other 510(k) Applications for this Company
Contact
SHAWN T HUXEL
Other 510(k) Applications for this Contact
Regulation Number
888.3010
More FDA Info for this Regulation Number
Classification Product Code
JDQ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/23/2002
Decision Date
03/11/2003
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