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FDA 510(k)

ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System

K-Number: K161466 · 2017-01-24

ApplicantOrthofix Srl
Decision Date2017-01-24
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System is a medical device manufactured by Orthofix Srl. It received FDA 510(k) clearance on 2017-01-24 under approval number K161466. 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 ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System?

ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System is a medical device that received FDA 510(k) clearance on 2017-01-24. It is manufactured by Orthofix Srl. The 510(k) number is K161466.

When was ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System approved by the FDA?

ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System received FDA 510(k) clearance on 2017-01-24, under approval number K161466.

What company makes ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System?

ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System is manufactured by Orthofix Srl.

What is the FDA product code for ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System?

The FDA product code for ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System is HSB.

Related Clinical Trials

NCT07520851 Efficacy of the Buzzy System on Pain and Fear Reduction in Elbow Fracture Pin Removal RECRUITING NCT04015128 A Post-Market Clinical Evaluation of the Treatment of Femur Fractures With the Femoral Nail GT ACTIVE_NOT_RECRUITING NCT04015154 A Post-Market Clinical Evaluation of the Treatment of Femur Fractures With the Femoral Nail PF COMPLETED NCT05773352 Perform® Humeral System - Fracture Study (PFX) ACTIVE_NOT_RECRUITING

Other Devices by Orthofix Srl

K153233Galaxy UNYCO System K173458ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System K173051Orthofix MJ-FLEX THE NEW METAIZEAU NAIL K170146Galaxy UNYCO System K170650Orthofix TrueLok Hexapod System (TL-HEX) V2.0 K180624Guided Growth Plate System Plus

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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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