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

DateFirm and productCodeLinked 510(k)
May 16, 2016Zimmer Manufacturing B.V.
M/DN Intramedullary Fixation 4.2 mm Diameter Cortical Screw, 3.5 mm Hex Head, 45 mm Length 00225304542 M/DN Intramedullary Fixation 4.2 mm Diameter Cortical Screw, 3.5 mm Hex Head, 70 mm Length 002253
Terminated
HSBK142281
Mar 12, 2016Zimmer Manufacturing B.V.
Product 60 consists of all product under product code: HSB and same usage: Item no: 225207055 RECON SCREW LG 5.5MM DIA 225207555 RECON SCREW LG 5.5MM DIA 225208055 RECON SCREW LG 5.5MM DIA 225208555
Terminated
HSBK965098
Mar 12, 2016Zimmer Manufacturing B.V.
Product 55 consists of all product under product code: HSB and same usage: Item no: 225900132 ONE-PIECE LAG SCREW 11MM 225900135 ONE-PIECE LAG SCREW 11MM 225900137 ONE-PIECE LAG SCREW 11MM 225900140
Terminated
HSBK032367
Mar 12, 2016Zimmer Manufacturing B.V.
Product 43 consists of all product under product code: HSB and same usage: Item no: 224001016 M/DN R-F IM NAIL 10MM DIA 224001018 M/DN R-F IM NAIL 10MM DIA 224001020 M/DN R-F IM NAIL 10MM DIA 224001
Terminated
HSBK142281
Mar 12, 2016Zimmer Manufacturing B.V.
Product 42 consists of all product under product code: HSB and same usage: Item no: 225224010 M/DN FEM IM NAIL 10MM DIA 225228010 M/DN FEM IM NAIL 10MM DIA 225230010 M/DN FEM IM NAIL 10MM DIA 225232
Terminated
HSBK965098
Mar 12, 2016Zimmer Manufacturing B.V.
Product 40 consists of all product under product code: HSB and same usage: Item no: 225706565 ITST ANTI-ROTATION SCREW 225707065 ITST ANTI-ROTATION SCREW 225708065 ITST ANTI-ROTATION SCREW 225708565
Terminated
HSBK032367
Mar 12, 2016Zimmer Manufacturing B.V.
Product 38 consists of all product under product code: HSB and same usage: Item no: 225303255 INTERLOCKING IM SCREW LG 225303555 INTERLOCKING IM SCREW LG 225303755 INTERLOCKING IM SCREW LG 225307055
Terminated
HSBK142281
Mar 12, 2016Zimmer Manufacturing B.V.
Product 37 consists of all product under product code: HSB and same usage: Item no: 225302055 INTERLOCKING IM SCREW LG 225303055 INTERLOCKING IM SCREW LG 225304055 INTERLOCKING IM SCREW LG 225304555
Terminated
HSBK965098
Mar 12, 2016Zimmer Manufacturing B.V.
Product 36 consists of all product under product code: HSB and same usage: Item no: 225302745 INTERLOCKING IM SCREW 4.5 225303045 INTERLOCKING IM SCREW 4.5 225303245 INTERLOCKING IM SCREW 4.5 225303
Terminated
HSBK143321
Mar 12, 2016Zimmer Manufacturing B.V.
Product 14 consists of all product under product code HSB , and same usage: Item no: 225600230 ASIA ONE-PIECE LAG SCREW 225600232 ASIA ONE-PIECE LAG SCREW 225600235 ASIA ONE-PIECE LAG SCREW 22560023
Terminated
HSBK032367
Feb 25, 2016Stryker Howmedica Osteonics Corp.
Stryker, T2 Fixation K-Wire 3 x 285mm WCH coated Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Terminated
HSBK131365
Feb 25, 2016Stryker Howmedica Osteonics Corp.
Stryker, Gamma K-Wire 3.2x450 mm, UNS-Thread Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Terminated
HSBK123401
Feb 25, 2016Stryker Howmedica Osteonics Corp.
Stryker, METAIZEAU Intramedullary Pin, 2.0 x 400 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Terminated
HSBK063225
Dec 4, 2015Synthes (USA) Products LLC
Trochanteric Fixation Nail- Advanced System-11MM/130 DEG TI CANN TFNA 420MM/Right Sterile (The TFN-ADVANCED Proximal Femoral Nailing System) The TFN-ADVANCED Proximal Femoral Nailing System is intende
Terminated
HSBK011857
Oct 15, 2015Synthes (USA) Products LLC
Synthes Screw Inserter; for use with Intramedullary Rod, orthopedic device. Used to secure the head element to the head element inserter to prevent disengagement during head element insertion.
Terminated
HSBK131548
Oct 14, 2015Zimmer Gmbh
Zimmer Natural Nail CM Long. Intramedullary Fixation Rod. The Zimmer Natural Nail System is intended for temporary fracture fixation and stabilization of the bone.
Terminated
HSBK091566
Jul 29, 2015Tornier, Inc
Aequalis Humeral Nail Targeting Jig, Product Code: 9020060. Orthopedic manual surgical instrument.
Terminated
HSBK082754
Jul 16, 2015Synthes (USA) Products LLC
Helical Blade Inserter for Trochanteric Fixation Nail-ADVANCED (TFNA); intended to secure the head element to the head element inserter to prevent disengagement during head element insertion. Manual
Terminated
HSBK131548
Jul 13, 2015Zimmer, Inc.
ZNN Antegrade Femoral Nail (ZNN AF). Orthopedic internal fixation device.
Terminated
HSBK083497
Jun 26, 2015Synthes, Inc.
DePuy Synthes 6.5 mm Titanium Recon Screws w/T25 Stardrive (70mm, 75mm, 80mm, 85mm, 90mm, 95mm, 105mm); part of the Expert Lateral Femur Nail System and indicated to stabilize Subtrochanteric fractur
Terminated
HSBK040336
Jun 8, 2015Vilex In Tennessee Inc
Vilex, Inc., FUZE 10.0 mm x 250 mm, Product # FZ100-250T-25. Ankle arthrodesis, tibio-talo-calcaneal arthrodesis.
Terminated
HSBK102413
Jun 8, 2015Vilex In Tennessee Inc
Vilex, Inc., FUZE 10.0 mm x 200 mm, Product # FZ100-200T-25. Ankle arthrodesis, tibio-talo-calcaneal arthrodesis.
Terminated
HSBK102413
Jun 8, 2015Vilex In Tennessee Inc
Vilex, Inc., FUZE 10.0 mm x 150 mm, Product # FZ100-150T-25. Ankle arthrodesis, tibio-talo-calcaneal arthrodesis.
Terminated
HSBK102413
May 12, 2015Synthes, Inc.
TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
Terminated
HSBK131548
Apr 29, 2015Pega Medical Inc.
Female Driver, Part number FDr101, instrument used for the insertion of the Fassier-Duval IM Telescopic System. For orthopedic procedures. This instrument is included in the Fassier-Duval IM Teles
Terminated
HSBK020885
K041393
Apr 2, 2015Pega Medical Inc.
GAP Nail 4.8mm (diameter size) of the GAP ENDO-EXO MEDULLARY SYSTEM. Catalog number GAP-N48-16; GAP-N48-18; GAP-N48-26; GAP-N48-28. Product Usage: The GAP Endo-Exo Medullary System is used for the t
Terminated
HSBK111232
Mar 30, 2015Synthes, Inc.
Synthes 130 Degree Aiming Arm and 125 Degree Aiming Arm; The 130 Degree Aiming Arm and 125 Degree Aiming Arm are a part of the TFN-ADVANCED (TFNA) System. The TFN-ADVANCED Proximal Femoral Nailing Sy
Terminated
HSBK131548
Nov 14, 2014Synthes, Inc.
10 mm/135 degree Titanium Cannulated Trochanteric Fixation Nail 170 MM - Sterile: intended to treat stable and unstable fractures of the proximal femur
Terminated
HSBK011857
Nov 12, 2014Medacta Usa
GMK Intramedullary Extension Rod 100 mm is a rod to obtain correct leg alignment during total knee replacement. Rod to obtain correct leg alignment during total knee replacement.
Terminated
HSBNone listed
Oct 14, 2014Stryker Howmedica Osteonics Corp.
Stryker T2 Tibia System Nail Insertion Sleeve, Elastic, Sterile, a) REF 1806-1406S, SPI 08-11 and b) REF 1806-1407S, SPI 08-13. Product Usage: The T2 Tibial Nailing system is intended to provide temp
Terminated
HSBK131365
Apr 18, 2014Pega Medical Inc.
Fassier-Duval IM Telescopic System. Orthopedic intramedullary rod implant. Catalogue number FD-040(L)-SS. -Duval IM Telescopic System.
Terminated
HSBK020885
K041393
Apr 10, 2014Pega Medical Inc.
Pega Medical Inc., Fassier-Duval IM Telescopic System, male component (solid shaft), Part number: M040-SS-110; Used in Implant Catalogue number: FD-040(LS)-SS. orthopedic intramedullary rod.
Terminated
HSBK020885
K041393
Feb 20, 2014Zimmer, Inc.
ONE-PIECE LAG SCREW 11MM. Item codes starting with 00225900.
Terminated
HSBK032367
Feb 20, 2014Zimmer, Inc.
ITST ANTI-ROTATION SCREW and FEM IM NAIL (10MM, 11 MM, 12 MM, 13 MM, 14 MM and 15 MM) DIA X (18, 30, 32, 34, 36, 38, 40, 42, 44, 46, 48 and 50)
Terminated
HSBK032367
Feb 20, 2014Zimmer, Inc.
ASIA ONE-PIECE LAG SCREW
Terminated
HSBK032367
Feb 20, 2014Zimmer, Inc.
M/DN HUMERAL I/M NAIL. Sizes from 6 MM to 13 MM. Codes starting with 0022541, 002542 and 0022543.
Terminated
HSBK965098
K965099 +3
Feb 20, 2014Zimmer, Inc.
INTERLOCKING IM SCREW SML, MED and LRG; M/DN TIBIAL I/M NAIL 6 MM to 15 MM. Some items starting with codes 0022530, 0022531, 002532, 0022533, 0022534
Terminated
HSBK965098
Feb 20, 2014Zimmer, Inc.
RECON SCREW LG 5.5MM DIA and M/DN FEM IM NAIL 8MM DIA to 16 MM DIA. Item codes starting with 0022520, 0022521, 002522, 0022523, 0022524 and 0022525.
Terminated
HSBK962561
K965098
Feb 20, 2014Zimmer, Inc.
M/DN R-F IM NAIL 9MM DIA , 10 MM, 11 MM, 12 MM, 13 MM and 14 MM. Item codes starting with 0022400
Terminated
HSBNone listed
Jan 28, 2014Stryker Howmedica Osteonics Corp.
Teflon Tube, sterile T2 Humerus System Stryker Trauma GmbH Prof Kuntscher Str 1-5 24232 Sconkidrchen, Germany distributed in the USA by: Stryker Howmedica Osteonics Corp.: Mahwah, NJ 07430 USA 510
Terminated
HSBK042396
Dec 27, 2013Zimmer, Inc.
TIB NAIL
Terminated
HSBK130595
Dec 27, 2013Zimmer, Inc.
TIBIO FEM/FEM NAIL.
Terminated
HSBK130595
Dec 10, 2013Synthes USA HQ, Inc.
Synthes Trochanteric Fixation Nail As part of the Synthes Trochanteric Fixation Nail (TFN) System, the TFN Nail is intended to treat stable and unstable fractures of the proximal femur.
Terminated
HSBK011857
Dec 5, 2013Synthes USA HQ, Inc.
Titanium Trochanteric Fixation Nail (TFN)System Intended to treat stable and unstable fractures of the proximal femur.
Terminated
HSBK011857
Nov 25, 2013Synthes USA HQ, Inc.
Large Buttress Compression Nut For Blade Guide Sleeve TFN The Synthes Large Buttress Compression Nut For Blade Guide Sleeve TFN is intended to treat stable and unstable pertrochanteric fractures, in
Terminated
HSBK011857
Nov 20, 2013Synthes USA HQ, Inc.
Synthes Titanium Trochanteric Fixation Nail (TFN)-Helical Blade Synthes Titanium Trochanteric Fixation Nail (TFN)-Helical Blade is used to treat stable and unstable fractures of the proximal femur in
Terminated
HSBK070294
Aug 26, 2013Synthes USA HQ, Inc.
Synthes Trauma Nail System. The devices are indication for bone fixation.
Terminated
HSBK011857
K033071 +3
Jul 31, 2013Stryker Howmedica Osteonics Corp.
GAMMA3 System Long Nail Kit, R2.0, Ti, Left Distributed in USA by Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430 USA A single use device intended for the temporary fixation, correc
Terminated
HSBNone listed
Jul 16, 2013Integra LifeSciences Corporation
Integra PANTA Arthrodesis Nail System. Intended for use in tibiotalocalcaneal arthrodesis and treatment of trauma to the hindfoot and distal tibia.
Terminated
HSBK050882
K091788
Apr 17, 2013Smith & Nephew Inc
TRIGEN (TM) L-P SCREW, 4.5 MM X 37.5 MM, TI-6AL-4V, QTY: (1), STERILE R, REF 71645437, Smith & Nephew, Inc. Memphis, TN 38116 USA orthopedic surgery
Terminated
HSBK111025

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