2 results
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18ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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Model No. 01-1503-0032 (Adolescent Nail Attachment Bolt). Component of the Pediatric Nailing Platform. Product Usage: an orthopedic implant system commonly referred to as an intramedullary fixation rod (product code HSB). The attachment bolts are one component of the surgical instruments within the system.
FDA Enforcement
Class II
·Terminated·OrthoPediatrics Corp·November 6, 2019
OrthoPediatrics Adolescent attachment bolt used with the Pediatric Nailing Platform (PNP) targeting arm- intended as an orthopedic implant system (bolt is used to attach the targeting arm to the intramedullary fixation rod) Part number: 01-1503-0032
FDA Enforcement
Class II
·Terminated·OrthoPediatrics Corp·October 23, 2019