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)
Top companies in HSB
| Company | 510(k)s | Recalls |
|---|---|---|
| Zimmer Biomet, Inc. | 0 | 295 |
| DePuy Orthopaedics, Inc. | 9 | 116 |
| Zimmer GmbH | 23 | 50 |
| Stryker | 12 | 37 |
| Howmedica Osteonics | 39 | 0 |
| OrthoPediatrics Corp. | 7 | 31 |
| Ebi, L.P. | 1 | 31 |
| Advanced Orthopaedic Solutions, Inc. | 15 | 12 |
| NuVasive Specialized Orthopedics | 18 | 9 |
| Synthes (Usa) | 23 | 4 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 23, 2016 | K160545 | GAP ENDO-EXO MEDULLARY SYSTEM Pega Medical, Inc., CA | HSB |
| Nov 7, 2016 | K161254 | Renovo Life Small Bone IM Nail System Renovo Life, LLC | HSB |
| Sep 26, 2016 | K160167 | DePuy Synthes TFNA Augmentation System Synthes (USA) Products, LLC | HSB |
| Apr 4, 2016 | K160325 | PRECICE Intramedullary Limb Lengthening System Ellipse Technologies, Inc. | HSB |
| Mar 31, 2016 | K160267 | PRECICE Trauma Nail System Ellipse Technologies, Incorporated | HSB |
| Mar 10, 2016 | K160069 | Sonoma Fibula Repair System Sonoma Orthopedics Products, Inc. | HSB |
| Jan 6, 2016 | K153536 | Piccolo Composite® Nailing System CarboFix Orthopedics , Ltd., IL | HSB |
| Dec 22, 2015 | K152370 | PRECICE Trauma Nail System Ellipse Technologies, Incorporated | HSB |
| Dec 17, 2015 | K151062 | WASTON Metallic Intramedullary Nail System Changzhou Waston Medical Appliance Co., Ltd., CN | HSB |
| Dec 14, 2015 | K150769 | Cardinal Health Trochanteric IM Nail System Cardinalhealth | HSB |
| Nov 13, 2015 | K152757 | SIGN Hip Construct (SHC) Sign Fracture Care International | HSB |
| Nov 3, 2015 | K152295 | Talon DistalFix Antegrade/Retrograde Femoral Nail Orthopedic Designs North America, Inc. | HSB |
| Oct 29, 2015 | K151456 | Small Bone Nail Implant Vilex IN Tennessee, Inc. | HSB |
| Sep 30, 2015 | K143245 | GPC Intramedullary Nailing Systems Gpc Medical Limited, IN | HSB |
| Jul 28, 2015 | K151010 | Piccolo Composite Nailing System CarboFix Orthopedics , Ltd., IL | HSB |
| Jul 10, 2015 | K143355 | The Simple Locking IntraMedullary (SLIM) System Pega Medical, Inc., CA | HSB |
| Jul 9, 2015 | K150655 | OIC Intramedullary Nail System Orthopaedic Implant Company | HSB |
| Jun 19, 2015 | K151131 | PRECICE Intramedullary Limb Lengthening System Ellipse Technologies, Incorporated | HSB |
| Jun 10, 2015 | K150867 | Affixus Tibial Nailing System Biomet, Inc. | HSB |
| Jun 3, 2015 | K143204 | AOS Clavicle Intramedullary Device Advanced Orthopaedic Solutions, Inc. | HSB |
| May 29, 2015 | K143321 | ITST Intertrochanteric/Subtrochanteric Fixation System Zimmer, Inc. | HSB |
| May 22, 2015 | K150471 | CalcaNail Orthopedic Arthrodesis Nail Fournitures Hospitalieres Industrie, FR | HSB |
| May 22, 2015 | K150463 | CalcaNail Orthopedic Nail Fournitures Hospitalieres Industrie, FR | HSB |
| Apr 23, 2015 | K150656 | PRECICE Intramedullary Limb Lengthening System Ellipse Technologies, Incorporated | HSB |
| Feb 10, 2015 | K150073 | MICRONAIL Distal Radius System Wrightmedicaltechnologyinc | HSB |
| Feb 9, 2015 | K142451 | OsteoBridge IDSF - Intramedullary Diaphyseal Segmental Defect Fixation Rod System Merete Medical GmbH, DE | HSB |
| Feb 5, 2015 | K143276 | Acumed Small Bone IM Nail System Acumed, LLC | HSB |
| Jan 22, 2015 | K142945 | Sonoma Fibula Repair System Sonoma Orthopedic Products, Inc. | HSB |
| Jan 16, 2015 | K142599 | PRECISE Trauma Nail System Ellipse Technologies, Incorporated | HSB |
| Nov 12, 2014 | K141571 | ORTHOFIX ANKLE HINDFOOT NAILING SYSTEM Orthofix Srl | HSB |
| Nov 6, 2014 | K133166 | INS HILDEN TIBIAL ARZZT Truemed Group, LLC | HSB |
| Oct 22, 2014 | K142602 | VALOR Hindfoot Fusion Nail System Wrightmedicaltechnologyinc | HSB |
| Oct 22, 2014 | K142281 | ZIMMER M/DN INTRAMEDULLARY FIXATION SYSTEM Zimmer, Inc. | HSB |
| Oct 7, 2014 | K141739 | RESIDUAL LIMB LENGTHENING SYSTEM Ellipse Technologies, Inc. | HSB |
| Oct 2, 2014 | K141347 | EMERGE MEDICAL IM NAIL SYSTEM Emerge Medical | HSB |
| Sep 23, 2014 | K141103 | INTRAMEDULLARY NAIL AND SCREWS-NEONAIL Neoortho Produtos Ortopedicos S/A | HSB |
| Jul 8, 2014 | K141228 | AOS 6.5MM CAPTURED, FULLY THREADED CANCELLOUS SCREW Advanced Orthopaedic Solutions, Inc. | HSB |
| Jul 2, 2014 | K140601 | FLOW-NAIL Flow-Fx, LLC | HSB |
| Jun 30, 2014 | K141447 | PRECICE TRAUMA NAIL SYSTEM Ellipse Technologies, Inc. | HSB |
| May 21, 2014 | K131609 | DOUBLE ENGINE INTRAMEDDULLARY NAIL SYSTEM Xiamen Double Engine Medical Material Co., Ltd., CN | HSB |
| May 20, 2014 | K141023 | PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM Ellipse Technologies, Inc. | HSB |
| Mar 31, 2014 | K131984 | SYNTHES SYNSONIC ULNA NAIL Synthes (Usa) | HSB |
| Mar 19, 2014 | K132078 | METALLIC INTRAMEDULLARY NAIL SYSTEM Tianjin Walkman Biomaterial Co., Ltd., CN | HSB |
| Mar 10, 2014 | K133104 | VAN HIP FRACTURE SYSTEM Epix Orthopaedic, Corp. | HSB |
| Mar 7, 2014 | K132945 | CFN-CANNULATED FEMUR NAIL, CTN-CANNULATED TIBIA NAIL, CHN-CANNULATED HUMERAL NAIL I.T.S. GmbH | HSB |
| Feb 28, 2014 | K131548 | SYNTHES TROCHANTERIC FIXATION NAIL - ADVANCED SYSTEM Synthes (USA) Products, LLC | HSB |
| Jan 23, 2014 | K131490 | ELLIPSE PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM Ellipse Technologies, Inc. | HSB |
| Jan 6, 2014 | K132830 | DISTALOCK TIBIAL IM NAIL SYSTEM Dgimed Ortho, Inc. | HSB |
| Dec 31, 2013 | K133081 | TROCHANTERIC NAILS AND ES TROCHANTERIC NAILS, HUMERAL NAISL, TIBIAL NAILS, ANTEGRADE FEMORAL NAILS, RETROGRADE FEMORAL N Advanced Orthopaedic Solutions, Inc. | HSB |
| Dec 20, 2013 | K132428 | IDEAL Jiangsu Ideal Medical Science & Technology Co., LT, CN | HSB |
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