Devices

Response BandLoc 5.5/6.0 Tensioner Instrument

Model / Serial
All lots Product Number: 01-1102-1000
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
Worldwide Distribution-US distribution to: MO, NY, KY, FL, NC and OH; and countries of: AUSTRALIA, FRANCE and SPAIN.
Product Description
Response BandLoc 5.5/6.0 Tensioner Instrument || The Tensioner Instrument (01-1102-1000) is utilized to allow the surgeon to apply a recommended tension to the band and hold it in place during spine manipulation and set screw tightening.
Manufacturer
OrthoPediatrics Corp
1 Event
- Recall of Response BandLoc 5.5/6.0 Tensioner Instrument

Manufacturer

OrthoPediatrics Corp

Manufacturer Address
OrthoPediatrics Corp, 2850 Frontier Dr, Warsaw IN 46582-7001
Manufacturer Parent Company (2017)
Orthopediatrics Corp
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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