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FDA 510(k) Application Details - K083469
Device Classification Name
Prosthesis, Toe, Hemi-, Phalangeal
More FDA Info for this Device
510(K) Number
K083469
Device Name
Prosthesis, Toe, Hemi-, Phalangeal
Applicant
METASURG
16350 PARK TEN PL., SUITE 101
HOUSTON, TX 77084 US
Other 510(k) Applications for this Company
Contact
MARK MYERS
Other 510(k) Applications for this Contact
Regulation Number
888.3730
More FDA Info for this Regulation Number
Classification Product Code
KWD
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/24/2008
Decision Date
02/13/2009
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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