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510(k) K192181

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 7, 2019
Date Received
August 12, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

Other clearances by Nuvasive Specialized Orthopedics, Inc.

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  • 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)
  • K193617 — Precice® Screws (May 8, 2020)
  • K193016 — PRECICE Bone Transport System (May 8, 2020)
  • K191336 — PRECICE System (September 26, 2019)
  • K182170 — PRECICE® BONE TRANSPORT™ System (February 5, 2019)

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