ClearanceBrief
Panels › Orthopedic › Product code HSB · Class 2

Rod, Fixation, Intramedullary And Accessories

Regulation 888.3020

20510(k)s in 12 months (532 all time)
19recalls in 12 months (690 all time)
680recalls that name a 510(k)
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Top companies in HSB

Company510(k)sRecalls
Zimmer Biomet, Inc.0295
DePuy Orthopaedics, Inc.9116
Zimmer GmbH2350
Stryker1237
Howmedica Osteonics390
OrthoPediatrics Corp.731
Ebi, L.P.131
Advanced Orthopaedic Solutions, Inc.1512
NuVasive Specialized Orthopedics189
Synthes (Usa)234
Decided510(k)Device and applicantCode
Sep 6, 2019K191782TTC Phantom Intramedullary Nail System
Paragon 28, Inc.
HSB
Sep 3, 2019K191617Syntec Tibial Nail System
Syntec Scientific Corporation, TW
HSB
Jul 18, 2019K191598AOS ES Retrograde Femoral Nail
Advanced Orthopaedic Solutions, Inc.
HSB
Jul 5, 2019K191238Zimmer Guide Wire Devices
Zimmer, Inc.
HSB
Jun 11, 2019K191271T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System, IMN Screws System, IMN Instruments System
Stryker Trauma GmbH, DE
HSB
Apr 11, 2019K181296Syntec Femoral Nail System
Syntec Scientific Corporation, TW
HSB
Feb 5, 2019K182170PRECICE® BONE TRANSPORT™ System
Nuvasive Specialized Orthopedics, Inc.
HSB
Jan 16, 2019K181540Estremo Citieffe Nailing System
Citieffe S.R.L., IT
HSB
Jan 14, 2019K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail System
Paragon 28, Inc.
HSB
Dec 14, 2018K183162Affixus Hip Fracture Nail
Biomet, Inc.
HSB
Dec 14, 2018K181827Affixus Natural Nail System Humeral Nail
Zimmer GmbH, CH
HSB
Nov 2, 2018K181639Panta 2 Arthrodesis Nail System
Integra LifeSciences Corporation
HSB
Oct 17, 2018K181026OsteoBridge™ IDSF System
Merete GmbH, DE
HSB
Oct 12, 2018K181640X-BOLT Hip Fracture Fixation System
X-Bolt Orthopaedics, IE
HSB
Aug 24, 2018K172830Double Medical Femoral Nail System
Double Medical Technology, Inc., CN
HSB
Jul 27, 2018K181184OIC Intramedullary Nail System
The Orthopaedic Implant Company
HSB
Jul 26, 2018K173656Arthrex FibuLock Nail
Arthrex, Inc.
HSB
Jul 17, 2018K181375Apex Femoral Nailing System
Orthoxel, IE
HSB
Jun 6, 2018K180436T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments System
Stryker Trauma GmbH, DE
HSB
May 10, 2018K172583OrthoPediatrics PediNail Intramedullary Platform
Orthopediatrics, Inc.
HSB
Apr 23, 2018K172699Agile Nail
Orthofix Srl, IT
HSB
Apr 3, 2018K180503PRECICE STRYDE System
Nuvasive Specialized Orthopedics, Inc.
HSB
Mar 15, 2018K173811TRIWAY Tibiotalocalcaneal (TTC) Arthrodesis System
In2bones Sas, FR
HSB
Feb 22, 2018K173255Talon DistalFix Humeral Nail
Orthopedic Designs North America, Inc.
HSB
Jan 16, 2018K172189Ins Hilden Humeral Arzzt, Ins Hilden Cannulated Tibial Arzzt, Ins Hilden Femoral Arzzt & Ins Hilden Retrograde Femoral A
Truemed Group, LLC
HSB
Jan 12, 2018K172774T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments System
Stryker Trauma GmbH, DE
HSB
Dec 29, 2017K171108AUTOBAHN Nailing System
Globus Medical, Inc.
HSB
Dec 28, 2017K173652Piccolo Composite Nailing System
CarboFix Orthopedics , Ltd., IL
HSB
Dec 20, 2017K170972Apex Tibial Nailing System
Orthoxel, IE
HSB
Dec 7, 2017K173458ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System
Orthofix Srl, IT
HSB
Dec 1, 2017K173129PRECICE System
Nuvasive Specialized Orthopedics, Inc.
HSB
Nov 14, 2017K172157DePuy Synthes Femoral Recon Nail System
Synthes (USA) Products, LLC
HSB
Nov 2, 2017K171376DynaNail TTC Fusion System
MedShape, Inc.
HSB
Oct 30, 2017K172943Flex-Thread Fibula Pin System
Intrafuse, LLC
HSB
Oct 13, 2017K163653NOVOS-NAIL Limb Lengthening System (LLS)
Smith & Nephew
HSB
Sep 25, 2017K172628PRECICE System
Nuvasive Specialized Orthopedics, Inc.
HSB
Sep 14, 2017K163627Shotel Ankle Arthrodesis Nail System
Biopro, Inc.
HSB
Aug 24, 2017K172061PRECICE UNYTE System
Nuvasive Specialized Orthopedics, Inc.
HSB
Aug 10, 2017K172114Zimmer Natural Nail System
Zimmer, Inc.
HSB
Jul 20, 2017K163589SIGN IM Nail
Sign Fracture Care International
HSB
Jun 9, 2017K170169PRECICE Intramedullary Limb Lengthening System
Nuvasive Specialized Orthopedics, Inc.
HSB
Jun 8, 2017K161327SYNTEC HUMERAL NAIL SYSTEM
Syntec Scientific Corporation, TW
HSB
Apr 6, 2017K162927PRECICE UNYTE CoCr System
Nuvasive Specialized Orthopedics, Inc.
HSB
Mar 20, 2017K163488Flex-Thread Clavicle Pin System
Intrafuse, LLC
HSB
Mar 7, 2017K170346PRECICE Intramedullary Limb Lengthening System
Nuvasive Specialized Orthopedics, Inc.
HSB
Feb 24, 2017K161371Sonoma Fifth Metatarsal Repair System
Sonoma Orthopedic Products, Inc.
HSB
Jan 26, 2017K163368FITBONE TAA
Wittenstein Intens GmbH, DE
HSB
Jan 24, 2017K163014AOS Small Bone Nailing System
Advanced Orthopaedic Solutions, Inc. (Aos)
HSB
Jan 24, 2017K161466ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System
Orthofix Srl, IT
HSB
Nov 23, 2016K161264TRIGEN Low Profile Bone Screws
Smith & Nephew, Inc.
HSB

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