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510(k) K160264

Additive Orthopaedics Hammertoe Correction System by Additive Orthopaedics, LLC — Product Code HTY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 1, 2016
Date Received
February 2, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pin, Fixation, Smooth
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type

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  • K163593 — Additive Orthopaedics Bunion System (June 20, 2017)
  • K170214 — Additive Orthopaedics Locking Lattice Plate (April 13, 2017)
  • K153207 — Additive Orthopaedics Bone Wedge System (September 7, 2016)

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