Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K103742
Device Classification Name
Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)
More FDA Info for this Device
510(K) Number
K103742
Device Name
Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)
Applicant
INTEGRA LIFESCIENCES
2 GOODYEAR
IRVINE, CA 92672 US
Other 510(k) Applications for this Company
Contact
JENNY FAM
Other 510(k) Applications for this Contact
Regulation Number
888.3045
More FDA Info for this Regulation Number
Classification Product Code
MBP
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/23/2010
Decision Date
03/17/2011
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