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510(k) K161279

Life Spine Metatarsal Hemi Implant by Life Spine, Inc. — Product Code KWD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 1, 2017
Date Received
May 6, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Toe, Hemi-, Phalangeal
Device Class
Class II
Regulation Number
888.3730
Review Panel
OR
Submission Type

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