International Medical Devices Database

Manufacturer Address
EBI Patient Care, Inc., 484 Calle E, Guaynabo PR 00969-3454
Source
USFDA
2 Events
- Recall of SpFPLUS Implantable Stimulator
- Recall of SpFXL IIB 2/DM Implantable Stimulator

2 devices in the database

SpFPLUS Implantable Stimulator

Model / Serial
Serial Numbers: 410093 410094 410096 410103 410111 410115 410119 410148 410151 410158, and 410171.
Product Classification
Orthopedic Devices
Device Class
3
Implanted device?
No
Distribution
Nationwide distribution only.
Product Description
10-1398M - SpF-PLUS Implantable Stimulator. || Indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels.

SpFXL IIB 2/DM Implantable Stimulator

Model / Serial
Serial Numbers: 224595 224598 224607 224608 224610 224613 224615 224621 224622 224623 224624 224625 224626 224644 224649 224651 224655 224656 224658 224659 224666, and 224667.
Product Classification
Orthopedic Devices
Device Class
3
Implanted device?
No
Distribution
Nationwide distribution only.
Product Description
10-1335M - SpF-XL IIB 2/DM Implantable Stimulator. || Indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels.

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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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EBI Patient Care, Inc.

2 devices in the database

SpFPLUS Implantable Stimulator

SpFXL IIB 2/DM Implantable Stimulator