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FDA 510(k)

PRECICE Plating System

K-Number: K192181 · 2019-11-07

ApplicantNuvasive Specialized Orthopedics, Inc.
Decision Date2019-11-07
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PRECICE Plating System is a medical device manufactured by Nuvasive Specialized Orthopedics, Inc.. It received FDA 510(k) clearance on 2019-11-07 under approval number K192181. The device is classified under product code KTT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRECICE Plating System?

PRECICE Plating System is a medical device that received FDA 510(k) clearance on 2019-11-07. It is manufactured by Nuvasive Specialized Orthopedics, Inc.. The 510(k) number is K192181.

When was PRECICE Plating System approved by the FDA?

PRECICE Plating System received FDA 510(k) clearance on 2019-11-07, under approval number K192181.

What company makes PRECICE Plating System?

PRECICE Plating System is manufactured by Nuvasive Specialized Orthopedics, Inc..

What is the FDA product code for PRECICE Plating System?

The FDA product code for PRECICE Plating System is KTT.

Other Devices by Nuvasive Specialized Orthopedics, Inc.

K160352MAGEC® Spinal Bracing and Distraction System K161751MAGEC® Spinal Bracing and Distraction System K173129PRECICE System K172628PRECICE System K172061PRECICE UNYTE System K170169PRECICE Intramedullary Limb Lengthening System

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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