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FDA 510(k) Application Details - K043248
Device Classification Name
Washer, Bolt Nut
More FDA Info for this Device
510(K) Number
K043248
Device Name
Washer, Bolt Nut
Applicant
ARTHREX, INC.
1370 CREEKSIDE BLVD.
NAPLES, FL 34108-1945 US
Other 510(k) Applications for this Company
Contact
SALLY FOUST
Other 510(k) Applications for this Contact
Regulation Number
888.3030
More FDA Info for this Regulation Number
Classification Product Code
HTN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/23/2004
Decision Date
02/16/2005
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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