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FDA 510(k)

Advanced Intramedullary Nail System

K-Number: K221221 · 2022-12-21

ApplicantDouble Medical Technology, Inc.
Decision Date2022-12-21
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Advanced Intramedullary Nail System is a medical device manufactured by Double Medical Technology, Inc.. It received FDA 510(k) clearance on 2022-12-21 under approval number K221221. 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 Advanced Intramedullary Nail System?

Advanced Intramedullary Nail System is a medical device that received FDA 510(k) clearance on 2022-12-21. It is manufactured by Double Medical Technology, Inc.. The 510(k) number is K221221.

When was Advanced Intramedullary Nail System approved by the FDA?

Advanced Intramedullary Nail System received FDA 510(k) clearance on 2022-12-21, under approval number K221221.

What company makes Advanced Intramedullary Nail System?

Advanced Intramedullary Nail System is manufactured by Double Medical Technology, Inc..

What is the FDA product code for Advanced Intramedullary Nail System?

The FDA product code for Advanced Intramedullary Nail System is HSB.

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Other Devices by Double Medical Technology, Inc.

K151458Double Medical Universal Spine System K172830Double Medical Femoral Nail System K172828Double Medical Cage System K220921Metal Bone Screw K233078Posterior Cervical Spine System K223753Cervical Plate 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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