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
Aug 9, 2023K231114Zimmer® Natural Nail® System Cephalomedullary Nails; Affixus® Natural Nail® Humeral Nail System
Zimmer Switzerland Manufacturing GmbH, CH
HSB
Jul 17, 2023K230257Arthrex Intramedullary Nails
Arthrex, Inc.
HSB
Jun 30, 2023K230456SGM Femoral Nail System
Changzhou Geasure Medical Apparatus and Instruments Co., Ltd., CN
HSB
Jun 9, 2023K230512Gamma4 System
Stryker GmbH
HSB
Mar 15, 2023K220234Precice Intramedullary Limb Lengthening System
Nuvasive Specialized Orthopedics, Inc.
HSB
Mar 6, 2023K221621Pro-X1™ Trochanteric Nailing System
X-Bolt Orthopedics, IE
HSB
Mar 3, 2023K221084Dyna Locking Trochanteric Nail™
Innosys, KR
HSB
Dec 21, 2022K221221Advanced Intramedullary Nail System
Double Medical Technology, Inc., CN
HSB
Dec 20, 2022K221031Arthrex DualCompression Hindfoot Fusion Nail Implant System
Arthrex, Inc.
HSB
Dec 6, 2022K221021Femoral Trochanteric Nail System – Neonail
Neoortho Produtos Ortopédicos S/A, BR
HSB
Nov 21, 2022K222390Flex-Thread™ Ulna Intramedullary Nail System
Flower Orthopedics Corporation Dba Conventus Flower
HSB
Nov 15, 2022K222309Gamma4 System
Stryker GmbH
HSB
Nov 14, 2022K210980Smith & Nephew Intramedullary Nail Systems
Smith & Nephew, Inc.
HSB
Oct 27, 2022K221489Artemis Proximal Femoral Nail System
Glw, Inc.
HSB
Sep 9, 2022K220659AUTOBAHN(R) EVO Femoral Nails
Globus Medical, Inc.
HSB
Jul 20, 2022K220679Pediatric Nailing Platform Femur
OrthoPediatrics Corp.
HSB
May 13, 2022K221115Flow-Nail
Flow-Fx, LLC
HSB
Feb 11, 2022K213328Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing System
Stryker GmbH
HSB
Feb 10, 2022K203811GPC Intraheal Intramedullary Nailing System
Gpc Medical Limited, IN
HSB
Dec 21, 2021K211086The Progen™ Trochanteric Nail System
Ortho Development Corporation
HSB
Jul 23, 2021K212030Flex-Thread™ Distal Fibula lntramedullary Nail System
Flower Orthopedics Corporation Dba Conventus Flower
HSB
Jul 19, 2021K201147Elos® Intramedullary Nailing System
Intrauma S.P.A, IT
HSB
Jun 28, 2021K210869Phantom Hindfoot TTC/TC Nail System
Paragon 28, Inc.
HSB
May 26, 2021K211292Fassier-Duval Telescopic IM System
Pega Medical, Inc., CA
HSB
Mar 18, 2021K210285Adaptable Ortho Innovations Intramedullary Nail System
Adaptable Ortho Innovations, LLC
HSB
Feb 26, 2021K203819T2 Alpha Femur Retrograde Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Tibial Nailing System, T2 Fe
Stryker GmbH
HSB
Feb 19, 2021K201379Artemis Proximal Femoral Nail System
Glw, Inc.
HSB
Feb 17, 2021K203399FITBONE(R) TAA
Wittenstein Intens GmbH, DE
HSB
Jan 22, 2021K202858Flex-ThreadTM Distal Fibula Intramedullary Nail System
Conventus Orthopaedics, LLC
HSB
Dec 22, 2020K202348External Remote Controller ERC 4P
Nuvasive Specialized Orthopedics, Inc.
HSB
Oct 28, 2020K202935Syntec Femoral Nail Extended System
Syntec Scientific Corporation, TW
HSB
Oct 1, 2020K200127TELEGRAPH® EVOLUTION Humeral Nailing System
FH Industrie, FR
HSB
Sep 23, 2020K201346DePuy Synthes Retrograde Femoral Nail Advanced System, DePuy Synthes Locking Screws for Medullary Nails, 5.0 mm
Synthes (USA) Products, LLC
HSB
Sep 16, 2020K200430Precice® Ankle Salvage System
Nuvasive Specialized Orthopedics, Inc.
HSB
Aug 28, 2020K202099AOS Galileo™ Trochanteric Nail System
Advanced Orthopaedic Solutions, Inc.
HSB
Aug 27, 2020K201830ANSER Clavicle Pin
BAAT Medical Products B.V., NL
HSB
Aug 10, 2020K201567Precice® Bone Transport System
Nuvasive Specialized Orthopedics, Inc.
HSB
Jul 22, 2020K200869Gamma3 System
Stryker Trauma GmbH
HSB
Jul 17, 2020K201227Phantom® Hindfoot TTC/TC Nail System
Paragon 28, Inc.
HSB
Jul 1, 2020K200880T2 Tibial Nailing System, T2 Femoral Nail System, T2 Supracondylar Nail System, T2 Recon Nail System, T2 Greater Trochan
Stryker GmbH
HSB
Jun 24, 2020K192710The Simple Locking Intramedullary (Slim) System
Pega Medical, Inc., CA
HSB
May 8, 2020K193617Precice® Screws
Nuvasive Specialized Orthopedics, Inc.
HSB
May 8, 2020K193016PRECICE Bone Transport System
Nuvasive Specialized Orthopedics, Inc.
HSB
Apr 28, 2020K200814Affixus(R) Natural Nail(R) System Humeral Nail
Zimmer GmbH, CH
HSB
Feb 23, 2020K193308T2 Alpha Tibia Nailing System, IMN Screws System
Stryker Trauma GmbH
HSB
Jan 31, 2020K192163TTC Phantom® Intramedullary Nail System
Paragon 28, Inc.
HSB
Nov 14, 2019K183666EBA One Nailing System
Citieffe S.R.L., IT
HSB
Oct 11, 2019K192312Zimmer Natural Nail System Cephalomedullary Nails
Zimmer GmbH, CH
HSB
Oct 9, 2019K190321Pediatric Nailing PlatformFemur
OrthoPediatrics Corp.
HSB
Sep 26, 2019K191336PRECICE System
Nuvasive Specialized Orthopedics, Inc.
HSB

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