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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: IMPIX-C; IMPIX-L
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: MEDICREA INTERNATIONAL
Registered Establishment Number: 1000432246
Owner/Operator: MEDICREA INTERNATIONAL
Owner/Operator Number: 9047903
Establishment Operations: Repackager/Relabeler; Specification Developer
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