FDA Device Establishments · JSON-LD · Markdown

X-BOLT ORTHOPEDICS

FEI 3010368646 · Complaint File Establishment per 21 CFR 820.198 Export Device to the United States But Perform No Other Operation on Device Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device · Status: Active

FEI Number3010368646
Owner / OperatorX-Bolt Orthopedics (#10085237)
AddressUnit 5 Northwood Court, Santry Dublin, D09AX54, IE
Mandatory US AgentMCRA
Registration expiry2026
Initial importer flagN
Registered products1
Product codes (top 20)HSB
Regulation § (21 CFR)888.3020
Proprietary namesPro-X1®

External sources

Source: openFDA. Public-domain (CC0).