Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

TTC Phantom Intramedullary Nail System

K-Number: K191782 · 2019-09-06

ApplicantParagon 28, Inc.
Decision Date2019-09-06
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 2019-09-06 under approval number K191782. 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 2019-09-06. It is manufactured by Paragon 28, Inc.. The 510(k) number is K191782.

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

TTC Phantom Intramedullary Nail System received FDA 510(k) clearance on 2019-09-06, under approval number K191782.

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

NCT07580651 Quality and Safety of Real-Time Brachytherapy Treatments: Clinical Implementation of a Multipoint Scintillation Detector for Treatment Monitoring NOT_YET_RECRUITING NCT07569575 Magnesium-Titanium Hybrid Intramedullary Nail System For Long Bone Fractures NOT_YET_RECRUITING

Other Devices by Paragon 28, Inc.

K170693Phantom Small Bone Intramedullary Nail System K182148SILVERBACK Gorilla Plating System K190365Baby Gorilla/Gorilla Plating System K190586Monster® Screw System K183690Tenodesis Screw System K183228HammerToe Compression System

View all 50 devices →

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.

↑