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FDA 510(k) Application Details - K111230
Device Classification Name
Screw, Fixation, Bone
More FDA Info for this Device
510(K) Number
K111230
Device Name
Screw, Fixation, Bone
Applicant
SYNTHES (USA) PRODUCTS LLC
1301 GOSHEN PKWY.
WEST CHESTER, PA 19380 US
Other 510(k) Applications for this Company
Contact
REBECCA BLANK
Other 510(k) Applications for this Contact
Regulation Number
888.3040
More FDA Info for this Regulation Number
Classification Product Code
HWC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/02/2011
Decision Date
05/24/2011
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
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