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FDA 510(k) Application Details - K132733
Device Classification Name
Washer, Bolt Nut
More FDA Info for this Device
510(K) Number
K132733
Device Name
Washer, Bolt Nut
Applicant
ORTHOHELIX SURGICAL DESIGNS, INC.
1065 Medina Rd.
SUITE 500
Medina, OH 44256 US
Other 510(k) Applications for this Company
Contact
BRIAN HOCKETT
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
09/03/2013
Decision Date
01/03/2014
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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