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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Classification Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
Product Code: MAX
Device Class: 2
Regulation Number: 888.3080
Medical Specialty: Orthopedic
Registered Establishment Name: 3D SYSTEMS - LAYERWISE
Registered Establishment Number: 3010705004
Owner/Operator: LayerWise nv
Owner/Operator Number: 10048431
Establishment Operations: Contract Manufacturer
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