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FDA 510(k) Application Details - K112658
Device Classification Name
Screw, Fixation, Bone
More FDA Info for this Device
510(K) Number
K112658
Device Name
Screw, Fixation, Bone
Applicant
OSTEOSPRING MEDICAL, INC
228 HAMILTON AVENUE,
3RD FLOOR
PALO ALTO, CA 94301 US
Other 510(k) Applications for this Company
Contact
J.D. WEBB
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
09/13/2011
Decision Date
12/12/2011
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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