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510(k) K191336

PRECICE System by Nuvasive Specialized Orthopedics, Inc. — Product Code HSB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 26, 2019
Date Received
May 17, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Rod, Fixation, Intramedullary And Accessories
Device Class
Class II
Regulation Number
888.3020
Review Panel
OR
Submission Type

Other clearances by Nuvasive Specialized Orthopedics, Inc.

  • K230765 — Precice Ankle Salvage System (August 29, 2023)
  • K220234 — Precice Intramedullary Limb Lengthening System (March 15, 2023)
  • K202348 — External Remote Controller ERC 4P (December 22, 2020)
  • K200430 — Precice® Ankle Salvage System (September 16, 2020)
  • K201567 — Precice® Bone Transport System (August 10, 2020)
  • K201543 — MAGEC® System (July 30, 2020)
  • K193016 — PRECICE Bone Transport System (May 8, 2020)
  • K193617 — Precice® Screws (May 8, 2020)
  • K192181 — PRECICE Plating System (November 7, 2019)
  • K182170 — PRECICE® BONE TRANSPORT™ System (February 5, 2019)

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