Agile Nail
K-Number: K172699 · 2018-04-23
ApplicantOrthofix Srl
Decision Date2018-04-23
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Agile Nail is a medical device manufactured by Orthofix Srl. It received FDA 510(k) clearance on 2018-04-23 under approval number K172699. 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 Agile Nail?
Agile Nail is a medical device that received FDA 510(k) clearance on 2018-04-23. It is manufactured by Orthofix Srl. The 510(k) number is K172699.
When was Agile Nail approved by the FDA?
Agile Nail received FDA 510(k) clearance on 2018-04-23, under approval number K172699.
What company makes Agile Nail?
Agile Nail is manufactured by Orthofix Srl.
What is the FDA product code for Agile Nail?
The FDA product code for Agile Nail is HSB.
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
K161466ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System
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.