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510(k) K180503

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 3, 2018
Date Received
February 26, 2018
Clearance Type
Special
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

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  • 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)
  • K191336 — PRECICE System (September 26, 2019)

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