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Company · US

Spinal Solutions, LLC

FDA 510(k) clearances and medical device recalls filed under this name, 2011 to 2011. Name variants (Inc, Corp, punctuation) are merged.

1510(k) clearances (0 in 12 months)

11recalls (0 in 12 months)

10recalls that name a 510(k)

Product codes

Code	Device	Records
MNI	Orthosis, Spinal Pedicle Fixation	8
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	2
KWQ	Appliance, Fixation, Spinal Intervertebral Body	1
MNH	Orthosis, Spondylolisthesis Spinal Fixation	1

Latest 510(k) clearances

Decided	510(k)	Device and applicant	Code
Dec 15, 2011	K110633	LANCER PEDICLE SCREW SYSTEM Spinal Solutions, LLC	MNH

Latest recalls

Date	Firm and product	Code	Linked 510(k)
May 27, 2013	Spinal Solutions, LLC Fang Screw 20mm Fang Plate 21mm Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for u Terminated	KWQ	K090415
May 27, 2013	Spinal Solutions, LLC Copperhead IBFD, Large Neutral, 6mm Copperhead IBFD, Large Neutral, 7mm Copperhead IBFD, Large Neutral, 8mm Copperhead IBFD, Large Neutral, 9mm Copperhead IBFD, Large Neutral, 10mm Copperhead IBF Terminated	MAX	K090064
May 27, 2013	Spinal Solutions, LLC 14 x 11 x 6mm 7 deg 14 x 11 x 7mm 7 deg 14 x 11 x 8mm 7 deg 14 x 11 x 9mm 7 deg 14 x 11 x 10mm 7 deg 14 x 11 x 11mm 7 deg 14 x 11 x 12mm 7 deg Product Usage: Spinal Solutions distributes a var Terminated	MNI	K110633
May 27, 2013	Spinal Solutions, LLC 12mm x 27mm x 8mm 12mm x 27mm x 9mm 12mm x 27mm x 10mm 12mm x 27mm x 11mm 12mm x 27mm x 12mm 12mm x 27mm x 13mm 12mm x 27mm x 14mm Product Usage: Spinal Solutions distributes a variety of spina Terminated	MNI	K110633
May 27, 2013	Spinal Solutions, LLC 60 mm Rod, Item #BG1660 Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and su Terminated	MNI	K110633
May 27, 2013	Spinal Solutions, LLC 50 mm Rod, Item #BG1650 Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and su Terminated	MNI	K110633
May 27, 2013	Spinal Solutions, LLC 40 mm Rod, Item #BG1640 Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and su Terminated	MNI	K110633
May 27, 2013	Spinal Solutions, LLC Set Screw, Item #BG3010 Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and su Terminated	MNI	K110633
May 27, 2013	Spinal Solutions, LLC 50 mm Screw, Item #BG7050 Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and Terminated	MNI	K110633
May 27, 2013	Spinal Solutions, LLC 45 mm Screw, Item #BG7045 Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and Terminated	MNI	K110633
Apr 22, 2013	Spinal Solutions, LLC APLIF Implants and Instruments, Part Numbers: 184008-10 Anterior Psoas Lumbar 18 x 40 x 08mm - 10degree 184010-10 Anterior Psoas Lumbar 18 x 40 x 10mm - 10degree 184012-10 Anterior Psoas Lumbar 18 Terminated	MAX	None listed

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