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



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact