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FDA 510(k)

Precice Intramedullary Limb Lengthening System

K-Number: K220234 · 2023-03-15

ApplicantNuvasive Specialized Orthopedics, Inc.
Decision Date2023-03-15
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Precice Intramedullary Limb Lengthening System is a medical device manufactured by Nuvasive Specialized Orthopedics, Inc.. It received FDA 510(k) clearance on 2023-03-15 under approval number K220234. 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 Intramedullary Limb Lengthening System?

Precice Intramedullary Limb Lengthening System is a medical device that received FDA 510(k) clearance on 2023-03-15. It is manufactured by Nuvasive Specialized Orthopedics, Inc.. The 510(k) number is K220234.

When was Precice Intramedullary Limb Lengthening System approved by the FDA?

Precice Intramedullary Limb Lengthening System received FDA 510(k) clearance on 2023-03-15, under approval number K220234.

What company makes Precice Intramedullary Limb Lengthening System?

Precice Intramedullary Limb Lengthening System is manufactured by Nuvasive Specialized Orthopedics, Inc..

What is the FDA product code for Precice Intramedullary Limb Lengthening System?

The FDA product code for Precice Intramedullary Limb Lengthening System is HSB.

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Other Devices by Nuvasive Specialized Orthopedics, Inc.

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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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