FDA-Device2012-11-28Class II
Spine Frontier Inspan compressors Part Number: 11-60004. Inspan compressors provide pressure to drive spikes of Inspan implants into the spinous process bone, resulting in fixation of the implant.
SpineFrontier, Inc.
Hazard
Inspan Compressors may break at weld causing a loss of compression
Sold states
Worldwide Distribution-USA (nationwide) including PR and the states of FL, MA, MO, OK, and TX, and the country of Mexico.
Affected count
17 units
Manufactured in
500 Cummings Ctr Ste 3500, N/A, Beverly, MA, United States
Products
Spine Frontier Inspan compressors Part Number: 11-60004. Inspan compressors provide pressure to drive spikes of Inspan implants into the spinous process bone, resulting in fixation of the implant.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0412-2013Don't want to check this manually?
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