4 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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Orthopedic manual surgical instrument Usage: Exeter Rasp Handle is a reusable instrument which is part of the Exeter femoral hip system. Exeter femoral rasps are assembled with the rasp handle and locked in place by closing down the lever on the rasp handle. The rasp handle is then used to guide the rasp into the patients femur and is impacted using a mallet in order to remove bone and further prepare the femur.
FDA Enforcement
Class II
·Terminated·Stryker Howmedica Osteonics Corp.·August 17, 2016
Dome Centric component (Reference 01.04227.005) from the Anatomical Shoulder (AS) System 2.0. The Dome Centric connects the Humeral Stem to the Humeral Head and allows setting an inclination and retroversion positioning. The Anatomical Shoulder System is intended for long-term implantation into the human shoulder joint in primary or revision, total or hemi shoulder arthroplasty. The system is intended to relieve pain and restore function in patients with adequate bone stock to support the prosthesis.
FDA Enforcement
Class II
·Terminated·Zimmer Gmbh·June 22, 2016
SSS Reprocessed Zimmer, Synthes, Stryker and Linvatec Drill Bits and Blades Surgical drill bits, blades, burs, chisels, rasps, taps and reamers are specially designed surgical accessories to help the surgeon cut and drill bone and bony structures. Reprocessed surgical accessories are indicated for use in patients requiring surgery involving bone and bony structures.
FDA Enforcement
Class II
·Terminated·Stryker Sustainability Solutions·November 18, 2015
REVERSE PROSTHESIS SHOULDER SYSTEM, SCREW, LOCKING BONE, RSP, 5mmX30mm long, REF: 506-03-130
FDA Enforcement
Class II
·Ongoing·Encore Medical, LP·October 18, 2023