Devices

Device Recall SpineFrontier PedFuse Pedicle Screw System

Model / Serial
Lot/Serial Numbers: 06440-0000, 06441-0000, AG24
Product Classification
Orthopedic Devices
Device Class
1
Implanted device?
No
Distribution
Nationwide Distribution including TX, OH, VA, and Washington, DC.
Product Description
lnline Persuader- PedFuse Pedicle Screw System; Part Number: 11-80164
Manufacturer
SpineFrontier, Inc.
1 Event
- Recall of Device Recall SpineFrontier PedFuse Pedicle Screw System

Manufacturer

SpineFrontier, Inc.

Manufacturer Address
SpineFrontier, Inc., 500 Cummings Ctr Ste 3500, Beverly MA 01915-6516
Manufacturer Parent Company (2017)
SpineFrontier, Inc.
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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