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FDA 510(k)

Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail System

K-Number: K182307 · 2019-01-14

ApplicantParagon 28, Inc.
Decision Date2019-01-14
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail System is a medical device manufactured by Paragon 28, Inc.. It received FDA 510(k) clearance on 2019-01-14 under approval number K182307. 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 Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail System?

Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail System is a medical device that received FDA 510(k) clearance on 2019-01-14. It is manufactured by Paragon 28, Inc.. The 510(k) number is K182307.

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

Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail System received FDA 510(k) clearance on 2019-01-14, under approval number K182307.

What company makes Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail System?

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

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

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

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Related PubMed Literature

PMID: 27660042 A medical device-grade T1 and ECV phantom for global T1 mapping quality assurance-the T Journal of cardiovascular magnetic resonance : official journal of the Society for Cardiovascular Magnetic Resonance (2016)

Other Devices by Paragon 28, Inc.

K170693Phantom Small Bone Intramedullary Nail System K182148SILVERBACK Gorilla Plating System K191782TTC Phantom Intramedullary Nail System K190365Baby Gorilla/Gorilla Plating System K190586Monster® Screw System K183690Tenodesis Screw 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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