99 results
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11ms
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Sources: EU EUDAMED, US FDA
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Classification: Class Ii
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Stryker Howmedica Osteonics; Stryker T2 Humerus System Teflon Tube, sterile; REF 1806-0073S The T2 Nailing System is designed to treat complex fractures in Humeral, Femoral, Tibial and Ankle applications. The Teflon Tube is an optional instrument used to exchange the Ball Tip Guide Wire with the Smooth Tip Guide Wire once reaming is completed. Stryker Stryker Trauma GmbH 24232 Schonkirchen, Germany distributed in USA by: Howmedica Osteonics Corp., 235 Corporate Drive,
FDA Enforcement
Class II
·Terminated·Stryker Howmedica Osteonics Corp.·January 2, 2013
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 K042396 Used in several T2 systems intended to support the exchange of the Ball Tip Guide Wires for Smooth Tip Guide Wires: T2 Tibial Nailing Systems, T2 Femoral Nailing Systems, T2 Ankle Nailing Systems, and T2 Humerus Nailing Systems
FDA Enforcement
Class II
·Terminated·Stryker Howmedica Osteonics Corp.·February 5, 2014
Disposable Paper Filter for Sterilization Containers Paper, Medical Accessory, 100 DISP, Paper F, Steri.Cases, New Shape, Manufactured and distributed by Stryker Leibinger GmbH & Co KG, Distributed in the USA by: Stryker Orthopedics, NON STERILE.
FDA Enforcement
Class II
·Terminated·Stryker Craniomaxillofacial Division·October 14, 2015
The Stryker Thoracic Pedicle Feeler 6002-350-000 is a smart instrument for remote control of the navigation software and creation of a pathway into the pedicle. The instrument has three types of buttons to remotely control the software: the UP, DOWN and SELECT buttons. The Pedicle Feeler is laser marked in 10 mm intervals to help indicate the depth in which the feeler tip has been inserted into the pedicle. Next to the navigational information, these depth indicators on the feeler tip are also helpful in determining the appropriate pedicle screw length.
FDA Enforcement
Class II
·Terminated·Stryker Instruments Div. of Stryker Corporation·April 4, 2018
GAM Kirschner Wire, Sterile R, T2 K-Wire, Sterile R and T2 K-Wire Recon, Stryker Trauma GmbH, Prof.-Kuntscher-Strasse 1-5, Schonkirchen, Germany 24232; T2 K-Wire, Sterile R Intended for the temporary stabilization of bone segments or fragments
FDA Enforcement
Class II
·Terminated·Stryker Howmedica Osteonics Corp.·December 28, 2016
Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.
FDA Enforcement
Class II
·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012
Femoral Nail, LEFT T2 GTN 8x300 mm. Catalog Number: 1850-0830S.
FDA Enforcement
Class II
·Ongoing·Stryker GmbH·June 18, 2025
Long Nail, RIGHT Gamma4 10x320mm x 125, component of the Gamma4 System. Catalog Number: 84250320S.
FDA Enforcement
Class II
·Ongoing·Stryker GmbH·June 18, 2025
Femoral Nail, RIGHT T2 GTN 8x300 mm. Catalog Number: 1851-0830S.
FDA Enforcement
Class II
·Ongoing·Stryker GmbH·June 18, 2025
Guide Wire with Ruler Tube 3x800 mm DIA; Catalog number/REF: 2351-3080S;
FDA Enforcement
Class II
·Ongoing·Stryker GmbH·April 23, 2025
Guide Wire with Ruler Tube 3x1000 mm DIA; Catalog number/REF: 2351-3100S;
FDA Enforcement
Class II
·Ongoing·Stryker GmbH·April 23, 2025
Stryker Hoffman LRF Wire Tensioner REF 4933-9-100, a component of the Hoffmann LRF System.
FDA Enforcement
Class II
·Ongoing·Stryker GmbH·July 3, 2024
Hinge Coupling Hoffmann LRF Catalog # 4933-0-800 Intended for fixation of fractures, joint contractures, fusions, limb lengthening, deformity correction, bone and soft tissue reconstruction in pediatric patients and adults.
FDA Enforcement
Class II
·Terminated·Stryker GmbH·May 2, 2018
Hoffman LRF Hexapod Strut, Extra Short 183mm-295mm, Model Number 4935-0-040. Product Usage - The Hoffmann LRF System is indicated in pediatric patients and adults for the treatment and fixation of: Open and closed fractures Post-traumatic joint contracture which has resulted in loss of range of motion Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction Pseudoarthrosis or non-union of long bones Limb lengthening by epiphyseal, diaphyseal, or metaphyseal distraction Correction of bony or soft tissue deformity Correction of segmental bony or soft tissue defects Joint arthrodesis Management of communicated intra-articular fractures of the distal radius Bone transport The Hoffmann LRF System is indicated in adults for: Osteotomy Revision procedure where other treatments or devices have been unsuccessful Bone reconstruction procedures Fusions and replantations of the foot Charcot foot reconstruction Lisfranc dislocations The typical LRF construct features two or more rings bridged by three to four telescopic struts with multiplanar, ball jointed fixation bolts. Once applied, the LRF can be unlocked for gross frame adjustment and fracture reduction. The LRF can be finely adjusted to aid in limb alignment and definitively locked to hold compression and reduction. If deemed appropriate, the LRF Telescopic Struts can provide up to 5mm of controlled dynamization. Original Statement OP-Tech H-ST-1_Rev2_HoffmannLRF_OpTech_2016-10690]
FDA Enforcement
Class II
·Terminated·Stryker GmbH·November 7, 2018
Ankle Arthrodesis Nail, right T2 Ankle ¿10x300mm, Product Number 18191030S
FDA Enforcement
Class II
·Terminated·Stryker GmbH·July 18, 2018
Femoral Nail, A/R, R1500 T2 Femur ¿12x300 mm, Product Number 18281230S
FDA Enforcement
Class II
·Terminated·Stryker GmbH·July 18, 2018
Farabeuf Clamp for 3.5mm Screws PRO, Catalog # 705463
FDA Enforcement
Class II
·Terminated·Stryker GmbH·June 27, 2018
Ankle Arthrodesis Nail, right T2 Ankle ¿11x300mm, Product Number 18191130S
FDA Enforcement
Class II
·Terminated·Stryker GmbH·July 18, 2018
Femoral Nail, A/R T2 Femur ¿10x340 mm, Product Number 18251034S
FDA Enforcement
Class II
·Terminated·Stryker GmbH·July 18, 2018
Femoral Nail, RIGHT T2 GTN ¿9x320 mm, Product Number 18510932S
FDA Enforcement
Class II
·Terminated·Stryker GmbH·July 18, 2018