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510(k) K153207

Additive Orthopaedics Bone Wedge System by Additive Orthopaedics, LLC — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 7, 2016
Date Received
November 5, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Fixation, Bone
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

Other clearances by Additive Orthopaedics, LLC

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  • K183011 — Additive Orthopaedics Patient Specific 3D Locking Lattice Plates (January 10, 2019)
  • K180239 — Additive Orthopaedics Patient Specific 3D Printed Bone Segments (May 16, 2018)
  • K163593 — Additive Orthopaedics Bunion System (June 20, 2017)
  • K170214 — Additive Orthopaedics Locking Lattice Plate (April 13, 2017)
  • K160264 — Additive Orthopaedics Hammertoe Correction System (June 1, 2016)

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