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HRS

1,320 FDA 510(k) clearances · Product code

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RecordFirmDate
PYTHON Plate Trial Instruments (K173930)Treace Medical Concepts, Inc.2018-03-19
Anchorage Bone Plating System (K172148)Stryker GmbH2018-03-19
TDM Plate and Screw System (K171808)Tdm Co., Ltd.2018-03-15
ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS Humerus and Olecranon Plates & MBOSS/FIXION Screws, ARMAR / ARTIS Tibia and Buttress Plates & MBOSS/FIXION Screws, ARMAR / ARTIS 2.4mm Plates & MBOSS/FIXION Screws, ARMAR/ ARTISClavical Hook Plate & MBOSS/FIXION Screws, ARMAR/ ARTIS Metaphyseal Plate & MBOSS/FIXION Screws, ARMAR / ARTISCalcaneal Plate & MBOSS/FIXION Screws (K171320)Meril Healthcare Pvt. , Ltd.2018-03-08
Activmotion Range (K173746)Newclip Technics2018-02-27
Osteotomy Truss System (OTS) (K172294)4Web, Inc.2018-02-22
Activ Ankle (K173641)Newclip Technics2018-01-16
EVOS Small Fragment Upper Extremity Plates (K173293)Smith & Nephew, Inc.2018-01-08
Alians Elbow Locking Plating System (K171372)Newclip Technics2018-01-04
Life Spine Foot and Ankle Plating System (K172973)Life Spine, Inc.2017-12-21
Breakaway Screw System (K172886)Paragon 282017-12-20
AxSOS 3 Ti (K172350)Stryker GmbH2017-12-15
MDS Plating System (K172786)Miami Device Solutions, LLC2017-12-08
OrthoPediatrics Wrist Fusion Plate (K172425)Orthopediatrics, Inc.2017-12-06
ARIX Humerus System (K172008)Jeil Medical Corporation2017-12-01
Ankle Fusion Plating System (K173121)In2bones Sas2017-11-28
CoLink View Plating System (K172300)In2bones USA, LLC2017-11-27
Minimally Invasive Bunion Plating System (K172178)Trilliant Surgical, Ltd.2017-11-16
ANTHEM Fracture System (K173166)Globus Medical, Inc.2017-11-13
EPIC Extremity Fracture Plate System (K172441)Epic Extremity, LLC2017-11-06
Omni Foot Plating System (K172260)Extremity Medical, LLC2017-11-06
G3™ Active Plate® Miniature System (K171293)Genesis Fracture Care, Inc.2017-10-23
ARIX Wrist System (K170705)Jeil Medical Corporation2017-09-21
DARCO Locking Bone Plate System (K171852)Wrightmedicaltechnologyinc2017-09-21
Footmotion Plating System (K171510)Newclip Technics2017-09-08
APTUS(R) Wrist 2.5 System (K172170)Medartis AG2017-09-08
Arthrex Mesh Plate System (K170547)Arthrex, Inc.2017-09-01
OrthoPediatrics Titanium PediPlates® System (K171173)OrthoPediatrics Corp.2017-08-24
EVOS Small Fragment Plating System (K172262)Smith & Nephew, Inc.2017-08-23
ARIX Ankle Fibula Hook Plate System (K170979)Jeil Medical Corporation2017-08-17
ARIX Foot System (2.3/2.8) (K170780)Jeil Medical Corporation2017-08-14
Arzzt 3.5 / 4.5 Small & Large Fragments System (K162507)Truemed Group, LLC2017-08-03
ARIX Ankle Distal Tibia System (K170313)Jeil Medical Corporation2017-07-27
ARIX Diaphysis System (K171285)Jeil Medical Corporation2017-07-24
In2Bones Fracture and Correction System (K170518)In2bones USA, LLC2017-07-14
DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist Fusion Plate (WFP) – MR Conditional, DePuy Synthes Large Fragment Dynamic Compression Locking (DCL) System –MR Conditional, DePuy Synthes Small Fragment Dynamic Compression Locking (DCL) System – MR Conditional, DePuy Synthes Modular Foot System – MR Conditional, DePuy Synthes T-Plates – MR Conditional, DePuy Synthes One-third Tubular Plate with Collar (OTPC) – MR Conditional, DePuy Synthes Stainless S (K160553)Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.2017-06-30
Distal Elbow Plating System (K171590)Skeletal Dynamics, LLC2017-06-27
VariAx 2 Compression Plating System (K170727)Stryker GmbH2017-06-22
Additive Orthopaedics Bunion System (K163593)Additive Orthopaedics, LLC2017-06-20
BioPro Foot Plating Systems (K162674)Biopro, Inc.2017-06-16
Alians Fragment Specific (K170843)Newclip Technics2017-06-16
EVOS Small Fragment Lower Extremity Plates (K170457)Smith & Nephew, Inc.2017-06-14
Piccolo Composite® Plate System (K170401)CarboFix Orthopedics , Ltd.2017-05-12
VariAx 2 Foot System (K170771)Stryker GmbH2017-05-08
Colink™ Plating System (K163293)In2bones USA, LLC2017-05-05
Locking Plate System (K162380)Beijing Keyi Medical Device Technology Co., Ltd.2017-05-02
ORTHOLOC® 3Di Ankle Fusion Plating System Line Extension (K163650)Wrightmedicaltechnologyinc2017-04-24
EVOS Small Fragment Plating System (K170887)Smith & Nephew, Inc.2017-04-24
Pantheon Medical Balanced Plating System (K162154)Pantheon Medical2017-04-24
GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS BRAND Of DHS/Dynamic Condylar Plate Plating System (K163383)Greens Surgicals Pvt. , Ltd.2017-04-19
Additive Orthopaedics Locking Lattice Plate (K170214)Additive Orthopaedics, LLC2017-04-13
ANTHEM™ Fracture System (K163361)Globus Medical, Inc.2017-04-07
Alians Clavicle range (K170310)Newclip Technics2017-03-30
NMUC Brand Small And Large Fragment Osteosynthesis Plating System, NMUC Brand of DHS/DCS Plating System (K163425)Narang Medical USA Corporation2017-03-24
Olecranon Plating System (K162898)Miami Device Solutions, LLC2017-03-17
Y3 Proximal Femoral Plate System (K163003)Pega Medical, Inc.2017-03-16
ORTHOLOC® 3Di Small Bones Plating (K163039)Wrightmedicaltechnologyinc2017-03-13
Level One Hand Plating System (K170124)KLS Martin L.P.2017-03-09
AlignMATE™ Lapidus Arthrodesis System (K162391)Arthrosurface, Inc.2017-02-21
VariAx Distal Radius Plating System, VariAx 2 System (K162841)Stryker GmbH2017-02-21
DePuy Synthes 2.4/2.7mm VA LCP Two-Column Volar Distal Radius Plate, Extra-Long (K163046)DePuy Synthes2017-02-09
APTUS® Coronoid 2.0 (K161861)Medartis AG2017-02-09
AxSOS 3 Ti; Stryker Plating System (K162439)Stryker GmbH2017-02-03
ORTHOLOC® 3Di Ankle Fracture Plating System (K163044)Wrightmedicaltechnologyinc2017-01-26
dynaMX™ Compression Plate (K161303)Mx Orthopedics, Corp.2017-01-26
osteo-WEDGE II ® Open Wedge Bone Locking Plate System (K162179)Graham Medical Technologies, LLC Dba Gramedica2017-01-10
VLP MINI-MOD 2.0mm Column Plates (K163086)Smith & Nephew, Inc.2016-12-21
Biomet Microfixation RibFix Blu Thoracic Fixation System (K162974)Biomet Microfixation2016-12-09
Medline UNITE® Ankle Fracture Plating System (K162829)Medline Industries, Inc.2016-12-09
Biomet Microfixation SternaLock 360 Sternal Closure System (K163007)Biomet Microfixation2016-11-23
aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5 (K161696)Aap Implantate AG2016-11-23
LOQTEQ® VA Distal Tibia Plate System: LOQTEQ® VA Distal Medial Tibia Plate 3.5; LOQTEQ® VA Distal Anterolateral Tibia Plate 3.5; LOQTEQ® VA Distal Fibula Plate 2.7/3.5 (K161747)Aap Implantate AG2016-11-22
EVOS Small Fragment Plating System (K162078)Smith & Nephew, Inc.2016-11-18
VLP Wrist Fracture System (K161665)Smith & Nephew, Inc.2016-11-15
AOS Small Fragment Plating System (K161913)Advanced Orthopaedic Solutions, Inc. (Aos)2016-11-04
LOQTEQ Distal Fibula Plate 3.5, Cancellous Screw 4.0, Washer (K161703)Aap Implantate AG2016-11-04
MatrixRIB Fixation System (K161590)Synthes (USA) Products, LLC2016-11-03
Footmotion Plating System (K161448)Newclip Technics2016-10-31
Distal Radius Plating System (K162635)Miami Device Solutions, LLC2016-10-21
Ulna Plating System (K162424)Biomet, Inc.2016-10-12
OrthoPediatrics Locking Proximal Femur System Cortical Screws (K162307)OrthoPediatrics Corp.2016-09-27
ARIX Hand System (K161746)Jeil Medical Corporation2016-09-21
Additive Orthopaedics Bone Wedge System (K153207)Additive Orthopaedics, LLC2016-09-07
Alians Elbow Locking Plating System (K152289)Newclip Technics2016-08-17
Tarsa-Link Stand-Alone Wedge Fixation System (K161037)Life Spine, Inc.2016-08-15
Distal Radius Plating System (K161292)Miami Device Solutions, LLC2016-08-15
Converge (K153573)Biomedical Enterprises, Inc.2016-08-11
ARIX Foot System (K161864)Jeil Medical Corporation2016-08-02
Biomet Microfixation Sternal Closure System (K161896)Biomet Microfixation2016-08-02
Conventus Orthopaedics Ulna Fixation System (K161048)Conventus Orthopaedics, Inc.2016-07-26
CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of DHS/DCS Plating System (K153374)Orthocare2016-06-17
NEOVIEW Plating System (K160995)In2bones Sas2016-06-10
AxSOS 3Ti (K153379)Stryker GmbH2016-05-26
OsteoMed ExtremiLOCK Wrist Plating System (K161041)Osteomed2016-05-19
BIOFOAM Bone Wedge (K152062)Wrightmedicaltechnologyinc2016-05-17
GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System. (K153716)Gpc Medical, Ltd.2016-05-17
Gridlock Ankle Plating System (K160177)Trilliant Surgical, Ltd.2016-04-22
G3(TM) Active Plate(R) Small Fragment System (K160633)Genesis Fracture Care, Inc.2016-04-22
MotoBand(TM) CP Implant System (K160300)Crossroads Extremity Systems, LLC2016-04-22
KLS Martin Thoracic Plating System (K153482)KLS-Martin L.P.2016-04-06
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