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510(k) K163593

Additive Orthopaedics Bunion System by Additive Orthopaedics, LLC — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 2017
Date Received
December 21, 2016
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

  • K211076 — Patient Specific Marking Guides (June 28, 2022)
  • K183011 — Additive Orthopaedics Patient Specific 3D Locking Lattice Plates (January 10, 2019)
  • K180239 — Additive Orthopaedics Patient Specific 3D Printed Bone Segments (May 16, 2018)
  • K170214 — Additive Orthopaedics Locking Lattice Plate (April 13, 2017)
  • K153207 — Additive Orthopaedics Bone Wedge System (September 7, 2016)
  • K160264 — Additive Orthopaedics Hammertoe Correction System (June 1, 2016)

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