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 8, 2018Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Right 125 11 mm x 380 mm, Item Number 814311380 Product Usage: Intended for the fixation of fractures
Terminated		 HSBK100238
Aug 8, 2018Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Right 125 11 mm x 360 mm, Item Number 814311360 Product Usage: Intended for the fixation of fractures
Terminated		 HSBK100238
Aug 8, 2018Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Right 125 11 mm x 340 mm, Item Number 814311340 Product Usage: Intended for the fixation of fractures
Terminated		 HSBK100238
Aug 8, 2018Zimmer Biomet, Inc.
Affixus Hip Fracture Nail 125 11mm x 180mm, Item Number 814311180 Product Usage: Intended for the fixation of fractures
Terminated		 HSBK100238
Aug 8, 2018Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Right 125 9 mm x 460 mm, Item Number 814311460 Product Usage: Intended for the fixation of fractures
Terminated		 HSBK100238
Aug 8, 2018Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Right 125 9 mm x 440 mm, Item Number 814309440 Product Usage: Intended for the fixation of fractures
Terminated		 HSBK100238
Aug 8, 2018Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Right 125 9 mm x 380 mm, Item Number 814309380 Product Usage: Intended for the fixation of fractures
Terminated		 HSBK100238
Aug 8, 2018Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Right 125 9 mm x 360 mm, Item Number 814309360 Product Usage: Intended for the fixation of fractures
Terminated		 HSBNone listed
Aug 8, 2018Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Right 125 9 mm x 340 mm, Item Number 814309340 Product Usage: Intended for the fixation of fractures
Terminated		 HSBK100238
Aug 8, 2018Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Right 125 9 mm x 320 mm, Item Number 814309320 Product Usage: Intended for the fixation of fractures
Terminated		 HSBK100238
Aug 8, 2018Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Right 125 9 mm x 300 mm, Item Number 814309300 Product Usage: Intended for the fixation of fractures
Terminated		 HSBK100238
Aug 8, 2018Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Right 125 9 mm x 260 mm, Item Number 814309260 Product Usage: Intended for the fixation of fractures
Terminated		 HSBK100238
Aug 8, 2018Zimmer Biomet, Inc.
Affixus Hip Fracture Nail 125 9 mm x 180 mm, Item Number 814309180 Product Usage: Intended for the fixation of fractures
Terminated		 HSBK100238
Jul 30, 2018Zimmer Biomet, Inc.
Zimmer Natural Nail Tibial Nail - Yellow 8.3mm, Model Number 47249534008 Product Usage - The Zimmer Natural Nail System is intended for temporary fracture fixation and stabilization of the bone. Indi
Terminated		 HSBK082770
Jun 27, 2018Stryker GmbH
Stryker T2 ANKLE ARTHRODESIS NAIL RIGHT 10MMX200MM Item Number: 1819-1020S T2 ANKLE ARTHRODESIS NAIL RIGHT 12MMX200MM 1819-1220S T2 LONG PROXIMAL HUMERAL NAIL LEFT 240mm1832-2824S T2 LONG PROXIMAL HUM
Terminated		 HSBK051590
Apr 27, 2018Stryker GmbH
Ankle Arthrodesis Nail, right T2 Ankle 11x300mm, Product Number 18191130S
Terminated		 HSBK003018
Apr 27, 2018Stryker GmbH
Ankle Arthrodesis Nail, right T2 Ankle 10x300mm, Product Number 18191030S
Terminated		 HSBK003018
Apr 27, 2018Stryker GmbH
Femoral Nail, RIGHT T2 GTN 14x460 mm, Product Number 18511446S
Terminated		 HSBK003018
Apr 27, 2018Stryker GmbH
Femoral Nail, RIGHT T2 GTN 9x320 mm, Product Number 18510932S
Terminated		 HSBK003018
Apr 27, 2018Stryker GmbH
Femoral Nail, LEFT T2 GTN 14x300 mm, Product Number 18501430S
Terminated		 HSBK003018
Apr 27, 2018Stryker GmbH
Femoral Nail, LEFT T2 GTN 12x360 mm, Product Number 18501236S
Terminated		 HSBK003018
Apr 27, 2018Stryker GmbH
Femoral Nail, LEFT T2 GTN 10x360 mm, Product Number 18501036S
Terminated		 HSBK003018
Apr 27, 2018Stryker GmbH
Femoral Nail, A/R, R1500 T2 Femur 12x380 mm, Product Number 18281238S
Terminated		 HSBK003018
Apr 27, 2018Stryker GmbH
Femoral Nail, A/R, R1500 T2 Femur 12x360 mm, Product Number 18281236S
Terminated		 HSBK003018
Apr 27, 2018Stryker GmbH
Femoral Nail, A/R, R1500 T2 Femur 12x300 mm, Product Number 18281230S
Terminated		 HSBK003018
Apr 27, 2018Stryker GmbH
Femoral Nail, A/R, R1500 T2 Femur 10x320 mm, Product Number 18281032S
Terminated		 HSBK003018
Apr 27, 2018Stryker GmbH
Femoral Nail, A/R T2 Femur 15x240 mm, Product Number 18251524S
Terminated		 HSBK003018
Apr 27, 2018Stryker GmbH
Femoral Nail, A/R T2 Femur 12x360 mm, Product Number 18251236S
Terminated		 HSBK003018
Apr 27, 2018Stryker GmbH
Femoral Nail, A/R T2 Femur 10x340 mm, Product Number 18251034S
Terminated		 HSBK003018
Apr 27, 2018Stryker GmbH
Femoral Nail, A/R T2 Femur 10x320 mm, Product Number 18251032S
Terminated		 HSBK003018
Apr 27, 2018Stryker GmbH
Tibial Nail, Standard T2 Tibia 12x315 mm, Product Number 18221231S
Terminated		 HSBK003018
Apr 3, 2018Zimmer Biomet, Inc.
Orthopedic Salvage System (OSS) Modular Arthrodesis 0 Degree Locking Collar, Model Number CP260600 Product Usage: The replacement of segmental defects of long bone, including midshaft replacement, an
Terminated		 HSBK042409
Mar 27, 2018Zimmer Biomet, Inc.
Phoenix Nail System, intended for use with an intramedullary nail system for alignment, stabilization and fixation of fractures. 3.5mm Inserter Connector, Short; Model Number: 14-441045; Kit Model Num
Terminated		 HSBK091976
Mar 26, 2018Zimmer Biomet, Inc.
Zimmer Natural Nail System Tear Drop Guide Wire 3.0 mm Diameter, 100 cm Length; Item Number: 47-2490-097-00
Terminated		 HSBK101622
Mar 26, 2018Zimmer Biomet, Inc.
Zimmer Natural Nail System Tear Drop Guide Wire 2.4 mm Diameter, 70 cm length; Item Number: 47-2490-098-01
Terminated		 HSBK101622
Mar 26, 2018Zimmer Biomet, Inc.
Zimmer Natural Nail System Tear Drop Guide Wire 3.0 mm Diameter, 70 cm length; Item Number: 47-2490-098-00
Terminated		 HSBK101622
Mar 14, 2018Wright Medical Technology, Inc.
WRIGHT, Wright Medical Technology, VALOR(R) Nail, Right, Small, OD: 11.5mm, L: 150mm, REF415101115R
Terminated		 HSBK090857
Mar 14, 2018Wright Medical Technology, Inc.
WRIGHT, Wright Medical Technology, VALOR(R) Nail, Right, Medium, OD: 10mm, L: 200mm, REF415101020
Terminated		 HSBK090857
Mar 14, 2018Zimmer Biomet, Inc.
ACE Trochanteric Nail System STER L H TROC NAIL 320X9X125 STER L H TROC NAIL 340X9X125 STER L H TROC NAIL 360X9X125 STER L H TROC NAIL 380X9X125 STER L H TROC NAIL 400X9X125 STER L H TROC NAIL 420X9X1
Terminated		 HSBK010780
K013563 +2
Mar 14, 2018Zimmer Biomet, Inc.
ACE Trochanteric Nail System ATN LAG SCREW 60MM STERILE ATN LAG SCREW 65MM STERILE ATN LAG SCREW 70MM STERILE ATN LAG SCREW 75MM STERILE ATN LAG SCREW 80MM STERILE ATN LAG SCREW 85MM STERILE ATN LAG S
Terminated		 HSBK010780
K013563 +2
Mar 14, 2018Zimmer Biomet, Inc.
ACE Trochanteric Nail System ATN AR SCREW 60MM STERILE ATN AR SCREW 65MM STERILE ATN AR SCREW 70MM STERILE ATN AR SCREW 75MM STERILE ATN AR SCREW 80MM STERILE ATN AR SCREW 85MM STERILE ATN AR SCREW 90
Terminated		 HSBK010780
K013563 +2
Mar 14, 2018Zimmer Biomet, Inc.
ACE Trochanteric Nail System STER TROC NAIL 180X13X140 STER TROC NAIL 125 DEG X 13MM STER TROC NAIL 130 DEG X 13MM STER TROC NAIL 135 DEG X 13MM The Trochanteric Nail System is intended to treat st
Terminated		 HSBK010780
K013563 +2
Mar 14, 2018Zimmer Biomet, Inc.
ACE Trochanteric Nail System TROCH NAIL ST 13X180 125DG STRL TROCH NAIL ST 13X180 130DG STRL TROCH NAIL ST 13X180 135DG STRL The Trochanteric Nail System is intended to treat stable and unstable prox
Terminated		 HSBK010780
K013563 +2
Mar 14, 2018Zimmer Biomet, Inc.
ACE Trochanteric Nail System STER TROC NAIL 180X11X140 STER TROC NAIL 125 DEG X 11MM STER TROC NAIL 130 DEG X 11MM STER TROC NAIL 135 DEG X 11MM The Trochanteric Nail System is intended to treat stab
Terminated		 HSBK010780
K013563 +2
Mar 14, 2018Zimmer Biomet, Inc.
ACE Trochanteric Nail System TROCH NAIL ST 11X180 125DG STRL TROCH NAIL ST 11X180 130DG STRL TROCH NAIL ST 11X180 135DG STRL The Trochanteric Nail System is intended to treat stable and unstable prox
Terminated		 HSBK010780
K013563 +2
Mar 14, 2018Zimmer Biomet, Inc.
ACE Trochanteric Nail System STER TROC LAG SCR 70 MM The Trochanteric Nail System is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, intertr
Terminated		 HSBK010780
K013563 +2
Mar 14, 2018Zimmer Biomet, Inc.
ACE Trochanteric Nail System STER TROC NAIL 125 DEG X 9MM STER TROC NAIL 130 DEG X 9MM STER TROC NAIL 135 DEG X 9MM The Trochanteric Nail System is intended to treat stable and unstable proximal frac
Terminated		 HSBK010780
K013563 +2
Mar 14, 2018Zimmer Biomet, Inc.
ACE Trochanteric Nail System STER TROC END CAP STER TROC END CAP 5MM STER TROC END CAP 10MM STER TROC END CAP 15MM STER TROC END CAP 20MM STER TROC END CAP 25MM The Trochanteric Nail System is intend
Terminated		 HSBK010780
K013563 +2
Mar 14, 2018Zimmer Biomet, Inc.
ACE Trochanteric Nail System ACE TROCH NAIL 125 DEG. X 11MM ACE TROCH NAIL 130 DEG. X 11MM ACE TROCH NAIL 135 DEG. X 11MM ACE TROCH NAIL 125 DEG. X 13MM ACE TROCH NAIL 130 DEG. X 13MM ACE TROCH NAIL 1
Terminated		 HSBK010780
K013563 +2
Mar 14, 2018Zimmer Biomet, Inc.
AIM Tibial Nails intramedullary fixation rod - NON-STERILE; Item numbers: 810508255 NAIL TIB DYN 08 X 25.5 810508270 NAIL TIB DYN 08 X 27.0 810508285 NAIL TIB DYN 08 X 28.5 810508300 NAIL TIB DYN 08 X
Terminated		 HSBK972183

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