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U.S. Department of Health and Human Services

510(k) Premarket Notification

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1 to 6 of 6 Results
ProductCode: GXN Applicant: SYNTHES (USA) Decision Date To: 05/02/2024
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depuy synthes craniomaxillofacial neuro devices - mr conditional Synthes (USA) Products LLC K192702 09/18/2020
synthes patient specific cranial/craniofacial implant SYNTHES (USA) K053199 12/14/2005
synthes (usa) patient specific cranial/craniofacial implants SYNTHES (USA) K033868 06/21/2004
synthes (usa) automated tack driver SYNTHES (USA) K021382 05/16/2002
synthes cranial flap tube clamp SYNTHES (USA) K992000 07/20/1999
synthes cranial flap twist clamp SYNTHES (USA) K991860 07/20/1999
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