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Precice Screws

FDA 510(k)

Class II (US FDA 510(k))

510(k) K193617

by Nuvasive Specialized Orthopedics, Inc.

Identifiers

510(k) Number
K193617 FDA 510(k)
FDA Product Code
HSB FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3020 FDA 510(k)
Regulation Number
888.3020 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Precice Screws are bone fixation fasteners that serve as accessories for the Precice limb‑lengthening and bone‑transport systems. They are used by orthopedic surgeons for fixation of long bones in procedures such as limb lengthening, open or closed fracture fixation, pseudoarthrosis, mal‑unions, non‑unions, and bone transport.

The screws are supplied sterile and are available in lengths ranging from 10 mm to 100 mm with a variety of thread styles, including pegs and partially or fully threaded options. They are cleared under FDA 510(k) (K193617, product code HSB) as an accessory to previously cleared Precice systems and are intended for use in clinical orthopedic settings.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PDF NuVasive Specialized Orthopedics, Inc. Regulatory Affairs Specialist ..., Precice® Screws (K193617) — FDA 510 (k) | Innolitics, NUVASIVE SPECIALIZED ORTHOPEDICS, INC. TSA5-065 PRECICE Screws

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Nuvasive Specialized Orthopedics, Inc.

Sources (1)

  • FDA 510(k) K193617 24 fields · synced Sep 25, 2026