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510(k) K183011

Additive Orthopaedics Patient Specific 3D Locking Lattice Plates by Additive Orthopaedics — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 10, 2019
Date Received
October 31, 2018
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

  • K211076 — Patient Specific Marking Guides (June 28, 2022)
  • 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)
  • K153207 — Additive Orthopaedics Bone Wedge System (September 7, 2016)
  • K160264 — Additive Orthopaedics Hammertoe Correction System (June 1, 2016)

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