Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K010532
Device Classification Name
Filler, Bone Void, Calcium Compound
More FDA Info for this Device
510(K) Number
K010532
Device Name
Filler, Bone Void, Calcium Compound
Applicant
WRIGHT MEDICAL TECHNOLOGY, INC.
5677 AIRLINE RD.
ARLINGTON, TN 38002 US
Other 510(k) Applications for this Company
Contact
EHAB M ESMAIL
Other 510(k) Applications for this Contact
Regulation Number
888.3045
More FDA Info for this Regulation Number
Classification Product Code
MQV
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/23/2001
Decision Date
10/26/2001
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