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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 the device name listed in this FDA 510(k) record. The listed applicant is Nuvasive Specialized Orthopedics, Inc.. It received FDA 510(k) clearance on 2019-11-07 under 510(k) 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. The listed applicant is Nuvasive Specialized Orthopedics, Inc.. The 510(k) number is K192181.

When did PRECICE Plating System receive FDA 510(k) clearance?

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

Who is the listed applicant for PRECICE Plating System?

The FDA 510(k) record lists Nuvasive Specialized Orthopedics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PRECICE Plating System?

The FDA product code for PRECICE Plating System is KTT.

Other records listing Nuvasive Specialized Orthopedics, Inc. as applicant

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Related Devices (Code: KTT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254087MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction SystemSynthes (USA) Products, LLCK260900DYNEX® External Fixation SystemsVilex, LLCK260112QuikFix External Fixator: Knee-Spanning PackStabiliz Orthopaedics, Inc.K253291Excelsior SystemBlue Ocean GlobalK253613Monkey Rings External Ring Fixation SystemParagon 28, Inc.K253202Hoffmann LRF SystemStryker GmbH

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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