FDA-Device2016-03-09Class II
Virage OCT Spinal Fixation System. Intended to promote fusion of the Occipital-Cervical-Thoracic spine (Occiput-T3).
Zimmer Spine, Inc.
Hazard
Zimmer Biomet Spine is initiating a Medical Device Correction regarding the Virage OCT Spinal Fixation System by providing additional guidance in the Virage OCT Surgical Technique Manual.
Sold states
Distributed US (nationwide) and in the countries of Australia and Germany.
Affected count
15,753
Manufactured in
7375 Bush Lake Rd, N/A, Minneapolis, MN, United States
Products
Virage OCT Spinal Fixation System. Intended to promote fusion of the Occipital-Cervical-Thoracic spine (Occiput-T3).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1019-2016Don't want to check this manually?
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