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FDA 510(k) Application Details - K161279
Device Classification Name
Prosthesis, Toe, Hemi-, Phalangeal
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510(K) Number
K161279
Device Name
Prosthesis, Toe, Hemi-, Phalangeal
Applicant
LIFE SPINE INC.
13951 S QUALITY DRIVE
HUNTLEY, IL 60142 US
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Contact
RANDY LEWIS
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Regulation Number
888.3730
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Classification Product Code
KWD
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More FDA Info for this Product Code
Date Received
05/06/2016
Decision Date
02/01/2017
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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