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FDA 510(k)

PRECICE Bone Transport System

K-Number: K193016 · 2020-05-08

ApplicantNuvasive Specialized Orthopedics, Inc.
Decision Date2020-05-08
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PRECICE Bone Transport System is a medical device manufactured by Nuvasive Specialized Orthopedics, Inc.. It received FDA 510(k) clearance on 2020-05-08 under approval number K193016. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRECICE Bone Transport System?

PRECICE Bone Transport System is a medical device that received FDA 510(k) clearance on 2020-05-08. It is manufactured by Nuvasive Specialized Orthopedics, Inc.. The 510(k) number is K193016.

When was PRECICE Bone Transport System approved by the FDA?

PRECICE Bone Transport System received FDA 510(k) clearance on 2020-05-08, under approval number K193016.

What company makes PRECICE Bone Transport System?

PRECICE Bone Transport System is manufactured by Nuvasive Specialized Orthopedics, Inc..

What is the FDA product code for PRECICE Bone Transport System?

The FDA product code for PRECICE Bone Transport System is HSB.

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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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Related Devices (Code: HSB)

K161264TRIGEN Low Profile Bone ScrewsSmith & Nephew, Inc. K160545GAP ENDO-EXO MEDULLARY SYSTEMPega Medical, Inc. K161254Renovo Life Small Bone IM Nail SystemRenovo Life, LLC K160167DePuy Synthes TFNA Augmentation SystemSynthes (USA) Products, LLC K160325PRECICE Intramedullary Limb Lengthening SystemEllipse Technologies, Inc. K160267PRECICE Trauma Nail SystemEllipse Technologies, Incorporated

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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