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510(k) K171327

Tyber Medical Wedge System by Tyber Medical, LLC — Product Code PLF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 16, 2017
Date Received
May 5, 2017
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bone Wedge
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

Intended to be used with ancillary fixation for opening wedge osteotomies or fusion in the ankle, foot, proximal tibia.

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