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FDA 510(k)

TTC Phantom® Intramedullary Nail System

K-Number: K192163 · 2020-01-31

ApplicantParagon 28, Inc.
Decision Date2020-01-31
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TTC Phantom® Intramedullary Nail System is a medical device manufactured by Paragon 28, Inc.. It received FDA 510(k) clearance on 2020-01-31 under approval number K192163. 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 TTC Phantom® Intramedullary Nail System?

TTC Phantom® Intramedullary Nail System is a medical device that received FDA 510(k) clearance on 2020-01-31. It is manufactured by Paragon 28, Inc.. The 510(k) number is K192163.

When was TTC Phantom® Intramedullary Nail System approved by the FDA?

TTC Phantom® Intramedullary Nail System received FDA 510(k) clearance on 2020-01-31, under approval number K192163.

What company makes TTC Phantom® Intramedullary Nail System?

TTC Phantom® Intramedullary Nail System is manufactured by Paragon 28, Inc..

What is the FDA product code for TTC Phantom® Intramedullary Nail System?

The FDA product code for TTC Phantom® Intramedullary Nail System is HSB.

Related Clinical Trials

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Other Devices by Paragon 28, 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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