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FDA 510(k) Application Details - K060253
Device Classification Name
Screw, Fixation, Bone
More FDA Info for this Device
510(K) Number
K060253
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
Lisa Simpson
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
02/01/2006
Decision Date
02/23/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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