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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: APPLIANCE, FIXATION, SPINAL INTERLAMINALOrthosis, spondylolisthesis spinal fixationORTHOSIS, SPINAL PEDICLE FIXATION
Classification Name: ORTHOSIS, SPONDYLOLISTHESIS SPINAL FIXATION
Product Code: MNH
Device Class: 2
Regulation Number: 888.3070
Medical Specialty: Orthopedic
Registered Establishment Name: 3D MEDICAL MANUFACTURING, INC. (dba Tecomet)
Registered Establishment Number: 3001239363
Premarket Submission Number: K010563
Owner/Operator: 3D Medical Manufacturing, inc. DBA Tecomet
Owner/Operator Number: 10043250
Establishment Operations: Contract Manufacturer
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