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Devices
thoracolumbosacral pedicle screw system
Model / Serial
Model number: 00-1300-0740, Lot number: M82791-1
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
US Nationwide Distribution
Product Description
Response 5.5/6.0 Spine System 7.0mm x 40mm || Pedicle Screw || Product Usage: || Posterior non-cervical pedicle screw fixation
Manufacturer
OrthoPediatrics Corp
1 Event
Recall of thoracolumbosacral pedicle screw system
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Manufacturer
OrthoPediatrics Corp
Manufacturer Address
OrthoPediatrics Corp, 2850 Frontier Dr, Warsaw IN 46582-7001
Manufacturer Parent Company (2017)
Orthopediatrics Corp
Source
USFDA
Language
English
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