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HRS

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

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RecordFirmDate
GMReis Ankle Plating System (K242998)GM Dos Reis Industria e Comercio Ltda.2024-11-21
Versalock Mini and Micro Plating System (K242596)GM Dos Reis Industria e Comercio Ltda.2024-11-21
Proximal Humerus Fixation System (K242436)Skeletal Dynamics, Inc.2024-11-14
Tandry Q-Locking Plate System (K242814)Microware Precision Co., Ltd.2024-11-14
Arthrex Elbow Fracture Plating System (K242079)Arthrex, Inc.2024-11-14
Osteotomy Truss System (OTS) (K240388)4Web Medical, Inc.2024-11-01
Bonebridge Osteosynthesis Plating System (K242399)Bonebridge AG2024-10-31
OIC Small / Mini Fragment Plate System (K242995)The Orthopaedic Implant Company2024-10-23
Arthrex VAL and VAL KreuLock™ Compression Screw System (K242554)Arthrex, Inc.2024-10-21
Clavicle and Scapula System (K240181)Auxein Medical Pvt., Ltd.2024-10-09
Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea Tibia Plating System (K242445)Stryker GmbH2024-10-06
BPS Wrist Fracture System (K242343)Orthonovis, Inc.2024-10-04
Protean Fragment Plating System (K241815)Skeletal Dynamics, Inc.2024-09-26
Pectus Blu Support Bar System (K241709)Biomet Microfixation2024-09-19
TriMed Bridge Plates (K241942)TriMed, Inc.2024-09-17
Fine Osteotomy™ (K241356)Bodycad Laboratories, Inc.2024-09-05
EVOS Patella Plates (K240487)Smith & Nephew2024-09-03
REDEMPTION Charcot Plating System (K233816)Vilex, LLC2024-08-28
SITTER 3.5mm Versatile System (K240318)Bonebridge AG2024-08-23
RibFix Titan™ Fixation System (K241282)Riverpoint Medical2024-08-19
NCB® Polyaxial Locking Plate System; NCB® Periprosthetic Femur Plate System; NCB® Cable Button; NCB® Straight Narrow Shaft Plate (K241754)Zimmer Switzerland Manufacturing GmbH2024-08-15
CoLink NeoFuse MIS Plating System (see attached parts list) (K241387)In2bones USA2024-08-13
Freefix Forearm Plating System (K242055)Skeletal Dynamics, Inc.2024-08-01
Activmotion S (K241539)Newclip Technics2024-07-30
VOLT™ Proximal Humerus 3.5 Plating System (K233994)Synthes GmbH2024-07-26
Gaudi Proximal Humerus Plate (K241296)Netbiologics, LLC2024-07-23
KLS Martin Orthopedic Implants - MR Conditional (K241018)KLS-Martin L.P.2024-07-12
Forma Medical Optimal Plating System (K234059)Forma Medical, Inc.2024-06-26
Versalock Rib and Sternum Plates System (K232829)GM Dos Reis Industria e Comercio Ltda.2024-06-26
APTUS Elbow Dorsal Olecranon Plates (K240613)Medartis AG2024-06-20
SIGNEX (K230546)Osteonic Co., Ltd.2024-06-11
Baby Gorilla/Gorilla Plating System; Monster Screw System (K241262)Paragon 28, Inc.2024-06-05
Tyber Medical Anatomical Plating System (K241218)Tyber Medical, LLC2024-05-31
NeoSpan® Compression Implant System (K233089)In2bones USA, LLC2024-05-24
DePuy Synthes MatrixSTERNUM Fixation System (K233967)Synthes GmbH2024-05-09
XLO Brand of Locking Distal Humerus Plating System (K233873)Ortho Life Systems Private Limited2024-04-26
Acumed Wrist Plating System (K233311)Acumed, LLC2024-04-22
APTUS Foot System 2.8-3.5 (K232105)Medartis AG2024-04-19
TriMed ASET Foot Plating System (1ST MTP 9-hole Long Plate), TriMed ASET Foot Plating System (1st Met Osteotomy Plate), TriMed ASET Foot Plating System (H-Plate), TriMed ASET Foot Plating System (Talonavicular Plate), TriMed ASET Foot Plating System (Calcaneal Slide Osteotomy Plate), TriMed ASET Foot Plating System (Evans Osteotomy Plate), TriMed ASET Foot Plating System (Medial Column Fusion Plate), TriMed ASET Foot Plating System (Straight Plate), TriMed ASET Foot Plating System (T- (K233863)TriMed, Inc.2024-04-17
Fine Osteotomy™ (K240703)Bodycad Laboratories, Inc.2024-04-12
TDM Large Bone Plate and Screw System (K232115)Tdm Co., Ltd.2024-04-05
VariAx 2 Distal Radius System (K233919)Stryker GmbH2024-03-25
APTUS Hand Scaphoid Plates (K234062)Medartis AG2024-03-21
DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment Plating System (K233665)DePuy Synthes2024-03-21
Treace Medical Systems (TMC) Plating System (K240173)Treace Medical Concepts, Inc.2024-02-22
HKT Anatomical Locking Trauma System (K231213)Hankil Tech Medical Co., Ltd.2024-01-19
Medline UNITE Ancillary Foot Recon Plating System (K234031)Medline Industires, LP2024-01-18
Quick - Radius Disposable Set (K231684)GM Dos Reis Industria e Comercio Ltda.2024-01-12
Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag System (K233423)Tyber Medical, LLC2023-12-21
SkyOPS™ Orthopedic Plate System (K233154)Sky Surgical, LLC2023-12-21
TM Plating System (K233017)Tyber Medical, LLC2023-12-20
Internal Locking Plate and Screw Fixation System (K232394)Changzhou Geasure Medical Apparatus and Instruments Co., Ltd.2023-12-15
ARIX Ankle Distal Tibia System (K231887)Jeil Medical Corporation2023-12-14
Anatomical Plating System (various) (K232652)Tyber Medical, LLC2023-12-13
Valkyrie Thoracic Fixation System (K232515)Jm Longyear Manufacturing, LLC D/B/A Able Medical Devices2023-12-08
Tyber Medical Distal Radius Plating System (K232693)Tyber Medical, LLC2023-12-04
TriLEAP Plating System (K230591)Crossroads Extremity Systems2023-09-29
Exactech Equinoxe PHx Fracture System; Exactech EPIC Screws (K223933)Exactech, Inc.2023-09-25
KITE Distal Fibula Kit (K230623)Intrauma S.P.A2023-09-01
TriMed Clavicle Fixation System (K230805)TriMed, Inc.2023-09-01
Distal Elbow Plating System (K231623)Skeletal Dynamics, Inc.2023-08-28
APS Metal Plate & Screw System (K223150)A Plus Biotechnology Co., Ltd.2023-08-24
Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System, Pangea Humerus Plating System (K231262)Stryker GmbH2023-08-18
Pangea Utility Plating System, Pangea Platform (K231257)Stryker GmbH2023-08-18
Sterile Products of the APTUS System (K232144)Medartis AG2023-08-18
Tandry Locking Plate System (K230690)Microware Precision Co., Ltd.2023-08-17
TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal Tibia System; LORRAINE 3.5mm Distal Humerus System (K231292)Bonebridge AG2023-07-19
ARIX Ankle System (K231441)Jeil Medical Corporation2023-07-17
APTUS® 3.5 TriLock Straight Plates (K230971)Medartis AG2023-06-02
Smith & Nephew ACCORD™ Cable System (K223762)Smith & Nephew2023-05-30
KLS Martin LINOS Wrist System (K222624)KLS-Martin L.P.2023-05-25
ARIX Humerus System (K230938)Jeil Medical Corporation2023-05-03
PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating System (K222381)Stryker GmbH2023-04-27
ALPHALOK Plating System (K230204)Vilex, LLC2023-04-25
PRO Plating System, Stryker Trauma Pelvic Set (Matta) (K223772)Stryker GmbH2023-04-07
Medartis APTUS® Ulna Plates (K223853)Medartis AG2023-03-30
MotoBAND™ CP Implant System: DynaBunion™ 4D Minimal-incision Bunion System, DynaMET™ Lesser TMT Fusion System (K223342)Crossroads Extremity Systems, LLC2023-03-30
KLS Martin Level One Rib Fixation System (K222397)KLS-Martin L.P.2023-03-29
WishBone Medical Plate and Screw System (K230527)Wishbone Medical, Inc.2023-03-29
KLS Martin Pure Pectus System (K221938)KLS Martin L.P.2023-03-28
LOQTEQ® VA Elbow Plates 2.7/3.5 System (K230141)Aap Implantate AG2023-03-17
Tyber Medical Anatomical Plating System (K222465)Tyber Medical, LLC2023-03-07
Tibia and Fibula System (K213059)Auxein Medical Private Limited2023-01-27
Advanced Bone Plate (K221150)Double Medical Technology, Inc.2023-01-25
Medline UNITE® Ankle Fusion Plating System (K222665)Medline Industries, Inc.2023-01-25
OIC Variable Angle Small Fragment Locking Plate System (K223118)Orthopaedic Implant Company2023-01-21
Anatomic Bone Plate (K221088)Double Medical Technology, Inc.2023-01-18
Treace Medical Concepts (TMC) Plating System (K221181)Treace Medical Concepts, Inc.2023-01-05
TriMed Wrist Fixation System 3 (K222637)TriMed, Inc.2022-12-21
ARIX Rib System (K221412)Jeil Medical Corporation2022-11-22
ALPHALOK Plating System (K221558)Vilex, LLC2022-11-15
Humerus & Ulna System (K213108)Auxein Medical Private Limited2022-11-04
HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System (K222282)Hospital Equipment Manufacturing Company2022-10-27
EVOS Wrist Spanning Plate (K213123)Smith & Nephew, Inc.2022-10-18
Varixis Elbow System (K213014)Auxein Medical Private Limited2022-10-03
Arthrex 2.4 mm Volar Distal Radius Plate System (K222267)Arthrex, Inc.2022-10-03
Arthrex 3.5 mm Locking Compression Plates (K222244)Arthrex, Inc.2022-09-30
Medline UNITE® Medial Malleolus Peg Plate System (K221360)Medline Industries, LP2022-09-27
DePuy Synthes 3.5mm Intrapelvic Acetabular System (K221809)DePuy Synthes2022-09-20
Bonebridge Osteosynthesis Plating System (K213864)Bonebridge AG2022-09-02
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