FDA-Device2018-02-28Class II
Radiolucent Surgery Spine Frame (F70801). Surgical platform used to position patients for lumbar spine procedures.
Allen Medical Systems
Hazard
The base of the frame has the potential to crack when the patient is initially transferred to the Bow Frame.
Sold states
Worldwide distribution. US Nationwide, Australia, Bangladesh, Brazil, Canada, China, Denmark, France, Germany, Greece, Italy, Japan, Korea, Kuwait, Lebanon, Malaysia, Netherlands, Spain, Switzerland, Taiwan, UAE, and UK.
Affected count
161 units total
Manufactured in
100 Discovery Way, N/A, Acton, MA, United States
Products
Radiolucent Surgery Spine Frame (F70801). Surgical platform used to position patients for lumbar spine procedures.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0642-2018Don't want to check this manually?
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