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FDA 510(k) Application Details - K050767
Device Classification Name
Screw, Fixation, Bone
More FDA Info for this Device
510(K) Number
K050767
Device Name
Screw, Fixation, Bone
Applicant
REGENERATION TECHNOLOGIES, INC.
11621 RESEARCH CIR.
P.O. BOX 2650
ALACHUA, FL 32616-2650 US
Other 510(k) Applications for this Company
Contact
CARRIE HARTILL
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
03/25/2005
Decision Date
06/09/2005
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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