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FDA 510(k) Application Details - K091686
Device Classification Name
Screw, Fixation, Bone
More FDA Info for this Device
510(K) Number
K091686
Device Name
Screw, Fixation, Bone
Applicant
JEIL MEDICAL CORPORATION
215 S. STATE STREET
STE: 100B
SALT LAKE CITY, UT 84111 US
Other 510(k) Applications for this Company
Contact
SHIN KUK YOO
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
06/09/2009
Decision Date
11/13/2009
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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