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
DateFirm and productCodeLinked 510(k)
Aug 7, 2017Zimmer Biomet, Inc.
Affixus Hip Fracture Nail, LH 130 DEG 11MM X 380MM
Terminated		 HSBK100238
Aug 7, 2017Zimmer Biomet, Inc.
Affixus Hip Fracture Nail, LH 130 DEG 11MM X 340MM
Terminated		 HSBK100238
Aug 7, 2017Zimmer Biomet, Inc.
Affixus Hip Fracture Nail, LH 130 DEG 11MM X 300MM
Terminated		 HSBK100238
Aug 7, 2017Zimmer Biomet, Inc.
Affixus Hip Fracture Nail, LH 130 DEG 11MM X 280MM
Terminated		 HSBK100238
Aug 7, 2017Zimmer Biomet, Inc.
Affixus Hip Fracture Nail, LH 130 DEG 11MM X 260MM
Terminated		 HSBK100238
Aug 7, 2017Zimmer Biomet, Inc.
Affixus Hip Fracture Nail, LH 125 DEG 9MM X 440MM
Terminated		 HSBK100238
Aug 7, 2017Zimmer Biomet, Inc.
Affixus Hip Fracture Nail, LH 125 DEG 9MM X 380MM
Terminated		 HSBK100238
Aug 7, 2017Zimmer Biomet, Inc.
Affixus Hip Fracture Nail, LH 125 DEG 9MM X 340MM
Terminated		 HSBK100238
Aug 7, 2017Zimmer Biomet, Inc.
Affixus Hip Fracture Nail, LH 125 DEG 9MM X 260MM
Terminated		 HSBK100238
Aug 7, 2017Zimmer Biomet, Inc.
Affixus Hip Fracture Nail, LH 125 DEG 11MM X 440MM
Terminated		 HSBK100238
Aug 7, 2017Zimmer Biomet, Inc.
Affixus Hip Fracture Nail, LH 125 DEG 11MM X 360MM
Terminated		 HSBK100238
Aug 7, 2017Zimmer Biomet, Inc.
Affixus Hip Fracture Nail, LH 125 DEG 11MM X 320MM
Terminated		 HSBK100238
Aug 7, 2017Zimmer Biomet, Inc.
Affixus Hip Fracture Nail, 130 DEG 9MM X 180MM
Terminated		 HSBK100238
Aug 7, 2017Zimmer Biomet, Inc.
Affixus Hip Fracture Nail, 130 DEG 11MM X 180MM
Terminated		 HSBK100238
Aug 7, 2017Zimmer Biomet, Inc.
Affixus Hip Fracture Nail, 125 DEG 9MM X 180MM
Terminated		 HSBK100238
Aug 7, 2017Zimmer Biomet, Inc.
Affixus Hip Fracture Nail, 125 DEG 11MM X 180MM
Terminated		 HSBK100238
Jul 21, 2017Synthes (USA) Products LLC
11MM/130 Degree Titanium Trochanteric Fixation Nail 380MM/Right, Sterile
Terminated		 HSBK011857
Apr 28, 2017Zimmer Biomet, Inc.
Z NAIL PF 14MM X 46CM UNIV Z NAIL GT 14MM X 46CM R Z NAIL GT 14MM X 46CM L Z NAIL TIBIA 14MM X 38CM UNIV Z NAIL TIBIA 14MM X 40CM UNIV Z NAIL TIBIA 14MM X 42CM UNIV Z NAIL TIBIA 14MM X 44CM UNIV
Terminated		 HSBK083497
Apr 28, 2017Zimmer Biomet, Inc.
FEM IM NAIL 14MMDX30CM LEFT, FEM IM NAIL 14MMDX30CM RIGHT FEM IM NAIL 13MMDX32CM LEFT FEM IM NAIL 14MMDX32CM LEFT FEM IM NAIL 13MMDX32CM RIGHT FEM IM NAIL 14MMDX32CM RIGHT FEM IM NAIL 11MMDX34CM
Terminated		 HSBK142281
Apr 28, 2017Zimmer Biomet, Inc.
TIBIAL I/M NAIL 15MMDX26CM, TIBIAL I/M NAIL 15MMDX28CM TIBIAL I/M NAIL 15MMDX30CM TIBIAL I/M NAIL 14MMDX32CM TIBIAL I/M NAIL 15MMDX32CM TIBIAL I/M NAIL 14MMDX34CM TIBIAL I/M NAIL 15MMDX34CM TIBI
Terminated		 HSBK142281
K965098
Apr 28, 2017Zimmer Biomet, Inc.
FEM IM NAIL 15MMDX30CM, FEM IM NAIL 16MMDX30CM FEM IM NAIL 14MMDX32CM FEM IM NAIL 15MMDX32CM FEM IM NAIL 16MMDX32CM FEM IM NAIL 14MMDX34CM FEM IM NAIL 15MMDX34CM FEM IM NAIL 16MMDX34CM FEM IM
Terminated		 HSBK965098
Apr 28, 2017Zimmer Biomet, Inc.
R-F IM NAIL 10MMDX48CM LG, 11MMDX42CM, 11MMDX44CM, 11MMDX46CM LG, 11MMDX48CM LG, 12MMDX46CM LG, 12MMDX48CM LG, 13MMDX40CM, 13MMDX42CM, 13MMDX44CM, 13MMDX46CM LG, 13MMDX48CM LG, 14MMDX34CM, 14MMDX36C
Terminated		 HSBK142281
Apr 19, 2017Ortho Solutions Inc
Oxford/Oxbridge AFN End Cap 10 mm x 5 mm tp 12 mm x10 mm The end caps are a circular disk with a small threaded shaft to be screwed to the distal end of the Nail.
Terminated		 HSBK121575
Apr 17, 2017Zimmer Biomet, Inc.
AFFIXUS Hip Fracture Nail Product Usage: The Hip Fracture Nail System is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, interochanteric
Terminated		 HSBK100238
Mar 20, 2017Zimmer Biomet, Inc.
Fem IM Nail 14mmdx50cm right, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
Terminated		 HSBK032367
Mar 20, 2017Zimmer Biomet, Inc.
Fem IM Nail 14mmdx50cm left, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
Terminated		 HSBK032367
Mar 20, 2017Zimmer Biomet, Inc.
Fem IM Nail 14mmdx48cm right, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
Terminated		 HSBK032367
Mar 20, 2017Zimmer Biomet, Inc.
Fem IM Nail 14mmdx48cm left, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
Terminated		 HSBK032367
Mar 20, 2017Zimmer Biomet, Inc.
Tibial IM Nail 15mmdx44cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
Terminated		 HSBK965098
Mar 20, 2017Zimmer Biomet, Inc.
Fem IM Nail 16mmdx50cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
Terminated		 HSBK965098
Mar 20, 2017Zimmer Biomet, Inc.
Fem IM Nail 15mmdx50cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
Terminated		 HSBK965098
Mar 20, 2017Zimmer Biomet, Inc.
Fem IM Nail 16mmdx48cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
Terminated		 HSBK965098
Mar 20, 2017Zimmer Biomet, Inc.
Fem IM Nail 15mmdx48cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
Terminated		 HSBK965098
Mar 20, 2017Zimmer Biomet, Inc.
Fem IM Nail 16mmdx46cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
Terminated		 HSBK965098
Mar 20, 2017Zimmer Biomet, Inc.
Fem IM Nail 15mmdx46cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
Terminated		 HSBK965098
Mar 20, 2017Zimmer Biomet, Inc.
Fem IM Nail 16mmdx44cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
Terminated		 HSBK965098
Mar 20, 2017Zimmer Biomet, Inc.
Fem IM Nail 15mmdx44cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
Terminated		 HSBK965098
Mar 20, 2017Zimmer Biomet, Inc.
Fem IM Nail 16mmdx42cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
Terminated		 HSBK965098
Mar 20, 2017Zimmer Biomet, Inc.
Fem IM Nail 16mmdx40cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
Terminated		 HSBK965098
Mar 20, 2017Zimmer Biomet, Inc.
Fem IM Nail 16mmdx38cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
Terminated		 HSBK965098
Mar 20, 2017Zimmer Biomet, Inc.
Por fullct fem st 20x200mm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
Terminated		 HSBK965098
Mar 3, 2017Integra LifeSciences Corp.
Panta Nail, Rx only, Sterile,
Terminated		 HSBK050882
K091788
Dec 22, 2016OrthoPediatrics Corp
OrthoPediatrics PediNail Intramedullary Nailing System 4.5mm X 48mm Cortical Screw
Terminated		 HSBK083726
Nov 19, 2016Synthes (USA) Products LLC
3.0 mm Reaming Rod/950 mm w/straight Ball Tip, Sterile
Terminated		 HSBNone listed
Nov 8, 2016Wright Medical Technology, Inc.
VALOR SCREW 5.0MM X 45MM LEN, Part Number 4151150045
Terminated		 HSBK090857
Sep 13, 2016Stryker Howmedica Osteonics Corp.
Femoral Nail, A/R T2 Femur 011x280 mm T2 Femoral Nailing System is one of the first femoral nailing systems to offer an option for either an antegrade or a retrograde approach to repair fractures of
Terminated		 HSBK010801
Sep 13, 2016Stryker Howmedica Osteonics Corp.
Supracondylar Nail T2 SCN 09x300 mm T2 Supracondylar Nail System is intended to provide strong and stable internal fixation with minimal soft tissue irritation of the distal femur. (1( Open and close
Terminated		 HSBK023267
Jun 14, 2016CarboFix Orthopedics, Ltd.
Piccolo Composite Tibia and Femoral Nailing Systems - Ball Tip Guide Wire for fixation of fractures that occur in and between the proximal and distal third of the long bones being treated.
Terminated		 HSBK102369
K111056 +2
May 26, 2016Biomet, Inc.
Various trauma and sports medicine instruments and implants. Rod, fixation, intramedullary and accessories.
Terminated		 HSBK050118
K063570 +2
May 16, 2016Zimmer Manufacturing B.V.
ITST intertrochanteric/subtrochanteric fixation 4.5 mm diameter cortical screw, 3.5 mm hex head, 57 mm length 00225305745
Terminated		 HSBK143321

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