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U.S. Department of Health and Human Services

Product Classification
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Device intervertebral fusion device with bone graft, solid-sphere, lumbar
Definition Intended to be inserted between the vertebral bodies into the disc space from l3 to s1 to provide stabilization and to help promote intervertebral body fusion. To be used with bone graft, for holding bone parts in alignment while they heal. Not intended for use in motion-sparing, non-fusion procedures, helps promote intervertebral body fusion, please reference: https://www.federalregister.gov/documents/2023/03/30/2023-06566/medical-devices-orthopedic-devices-classification-of-spinal-spheres-for-use-in-intervertebral-fusion.
Physical State Cobalt chrome spheres
Technical Method Inserted between the vertebral bodies in the disc space.
Target Area Intervertebral disc space from L3 to S1.
Review Panel Orthopedic
Product CodeNVR
Premarket Review Spinal Devices (DHT6B)
Spinal Devices (DHT6B)
Submission Type PMA
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Eligible
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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