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U.S. Department of Health and Human Services

510(K) Premarket Notification
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Device Name
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510(K)
Number
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plexur m Osteotech, Inc. k073405 03/03/2008
osteonics cement restrictor Osteonics Corp. k900462 03/06/1990
r120 modular total hip system Osteoimplant Technology, Inc. k011774 09/05/2001
unifit femoral stem Osteo Technology, Inc. k922871 02/12/1993
orthovita piston syringe or imbibe bone marrow aspiration syringe Orthovita, Inc. k011087 09/19/2001
vitros chemistry products calibrator kit 99, vitros chemistry products aat/hpt performance verifier i, ii, and iii Ortho-Clinical Diagnostics, Inc. k060940 04/24/2006
ortho aligner system Ortho Lab Services, LLC k212496 11/04/2021
betaject bd u100 Orange Medical Instruments, Inc. k833705 05/09/1984
flexible fiber-optic nasopharyngoscope Optimed Technologies, Inc. k895245 11/17/1989
optyse ophthalmoscope Ophthalmos , Ltd. k061278 05/16/2006

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