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FDA 510(k) Application Details - K002652
Device Classification Name
Bone Cement
More FDA Info for this Device
510(K) Number
K002652
Device Name
Bone Cement
Applicant
STRYKER CORP.
4100 E MILHAM AVE.
PORTAGE, MI 49002-9704 US
Other 510(k) Applications for this Company
Contact
SUZANNE VELAZQUEZ
Other 510(k) Applications for this Contact
Regulation Number
888.3027
More FDA Info for this Regulation Number
Classification Product Code
LOD
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/25/2000
Decision Date
01/26/2001
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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