Devices

Device Recall SpineFrontier

Model / Serial
Revision E
Product Classification
General and Plastic Surgery Devices
Device Class
1
Implanted device?
No
Distribution
US Nationwide Distribution in the states of TX, KS, CO, and MA
Product Description
SpineFrontier MISquito Percutaneous Pedicle Screw System Surgical Technique; Part Number: DOC80023. The Rod Caliper is a manual surgical instrument that may be used as part of the PedFuse Pedicle Screw System and its MISquito components during percutaneous, minimally invasive surgical (MIS) technique of posterior pedicle screw fixation.
Manufacturer
SpineFrontier, Inc.
1 Event
- Recall of Device Recall SpineFrontier

Manufacturer

SpineFrontier, Inc.

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

2 devices with a similar name

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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.

Device Recall SpineFrontier SLift Lock Shaft Inserter

Model / Serial
S-Lift Lock Shaft Part number; SI50001 Revisions: A, B Lots: 42613, 2478901R, 42615, 7625701
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
US Nationwide - OR, FL, MA, TX, CO, OK, IL, and MO
Product Description
SpineFrontier S-Lift Lock Shaft Inserter, an instrument used with S-LIFT Intervertebral Body Fusion Device in spinal fusion surgery. Product Usage: The S-Lift Lock Shaft SI50001 mates with SI50002, Implant Inserter, to aid in securing the implant to the whole implant inserter assembly, SI50000.
Manufacturer
SpineFrontier, Inc.

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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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