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NuVasive Specialized Orthopedics, Inc.

Last updated September 17, 2026

Information

Country: US
Address: 2560 General Armistead Ave, Audubon, PA, 19403
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EUDAMED SRN: —
FDA FEI Number: 3006179046
DUNS Number: —

Catalogue (2579)

Page 2 of 52

Device	Model / Reference	Registries	Class	Status
PRECICE® Intramedullary Limb Lengthening System	PR9.5-50A230	FDA UDI	Class II	Active
PRECICE System	HTO2-001	FDA UDI	Class I	Active
PRECICE® Intramedullary Limb Lengthening System	P003	FDA UDI	Class II	Active
MAGEC® Spinal Bracing and Distraction System	MS2-4590S	FDA UDI	Class II	Active
PRECICE® Intramedullary Limb Lengthening System	TSA4-200-S	FDA UDI	Class II	Active
Precice	TPT5-350-S	FDA UDI	Class II	Active
PRECICE® Intramedullary Limb Lengthening System	CPA2-005	FDA UDI	Class II	Active
PRECICE® Intramedullary Limb Lengthening System	TSA4-100	FDA UDI	Class II	Active
Precice	AST10.0-40200	FDA UDI	Class II	Active
PRECICE® STRYDE System	PS10.0-80A280	FDA UDI	Class II	Active
MAGEC® Spinal Bracing and Distraction System	MC2-5570S	FDA UDI	Class II	Active
Precice®	LBA1-001	FDA UDI	Class I	Active
PRECICE® Intramedullary Limb Lengthening System	LSB3-035	FDA UDI	Class II	Active
PRECICE® STRYDE System	PS10.0-80X280	FDA UDI	Class II	Active
PRECICE® Bone Transport System	BT115-10SA400-5	FDA UDI	Class II	Active
Precice®	DBAS-3.5	FDA UDI	Class I	Active
PRECICE® Bone Transport System	BT13-90A340-5	FDA UDI	Class II	Active
PRECICE® Bone Transport System	BT115-80SA320-7	FDA UDI	Class II	Active
PRECICE® Bone Transport System	BT13-80DT320-7	FDA UDI	Class II	Active
PRECICE® Intramedullary Limb Lengthening System	TSA5-375-S	FDA UDI	Class II	Active
PRECICE® System	SBIT-3.5	FDA UDI	Class I	Active
Precice	LSB3-200-S	FDA UDI	Class II	Active
PRECICE® Intramedullary Limb Lengthening System	HEC5-000	FDA UDI	Class II	Active
PRECICE® Bone Transport System	STP3.5-225	FDA UDI	Class II	Active
Precice	CTN4.5-028-S	FDA UDI	Class II	Active
Precice®	SFT4-425-S	FDA UDI	Class II	Active
PRECICE® Bone Transport System	BT115-70B300-7	FDA UDI	Class II	Active
Precice® Ankle Salvage System	AS10.0-40300-NT	FDA UDI	Class II	Active
PRECICE® System	TSA4.5-080	FDA UDI	Class II	Active
PRECICE® Instruments	PGA1-003	FDA UDI	Class II	Active
PRECICE® Intramedullary Limb Lengthening System Instrument	THA1-000	FDA UDI	Class I	Active
PRECICE® Instruments	LBT2-001	FDA UDI	Class II	Active
PRECICE® Bone Transport System	BT10-70C300-5	FDA UDI	Class II	Active
PRECICE® System	TSA4.5-100	FDA UDI	Class II	Active
Precice	CTL4.5-030-S	FDA UDI	Class II	Active
PRECICE® Bone Transport System	BT115-80SJ320-7	FDA UDI	Class II	Active
MAGEC® Spinal Bracing and Distraction System	MC2-5590R	FDA UDI	Class II	Active
PRECICE® Trauma Nail System	T10.7-80A255	FDA UDI	Class II	Active
PRECICE® Trauma Nail System	CDT12.5-30T270	FDA UDI	Class II	Active
PRECICE® Intramedullary Limb Lengthening System	P8.5-30H170	FDA UDI	Class II	Active
PRECICE® Intramedullary Limb Lengthening System	P8.5-50E215	FDA UDI	Class II	Active
PRECICE Screws	PSA4-050	FDA UDI	Class II	Active
PRECICE® STRYDE System	PS13.0-50X235	FDA UDI	Class II	Active
PRECICE® Bone Transport System	BT13-10X380-7	FDA UDI	Class II	Active
PRECICE® STRYDE System	PS13.0-50A235	FDA UDI	Class II	Active
PRECICE® STRYDE System	PS11.5-80E280	FDA UDI	Class II	Active
PRECICE® Intramedullary Limb Lengthening System	P003	FDA UDI	Class II	Active
PRECICE® Intramedullary Limb Lengthening System	PR9.0-80A335	FDA UDI	Class II	Active
PRECICE® Bone Transport System	BT10-10D360-7	FDA UDI	Class II	Active
Precice	STP5-325-S	FDA UDI	Class II	Active

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FDA Recalls (11)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Sep 30, 2024	Z-0500-2025	—	open, classified	Due to potential issues with design, manufacturing and documentation issues related to the validation of the affected products/devices.
Nov 1, 2022	Z-0559-2023	—	open, classified	During accelerated shelf-life extension studies it was noted that the final packaging was experiencing a potential of failure of the sterile packaging barrier which could result in a hazardous situation where the device is no longer sterile.
Oct 29, 2021	Z-0319-2022	—	open, classified	The Instructions for Use have been updated to include: (1) Clarification that the device is intended for use only in patients 18 years and older, (2) That patients should weigh 50 lbs. or more while undergoing treatment, and (3) That no more than two devices should be implanted at a time.
Feb 12, 2021	Z-1350-2021	—	open, classified	Due to not having the full complement of biological assessments for all potential patients and as a result the devices are not indicated for use in individuals under the age of 18 years old.
Feb 12, 2021	Z-1324-2021	—	open, classified	Due to complaints of adverse events potentially related to biological safety. The complaints included report of pain and bony abnormalities at the interface between the telescoping nail segments.
Feb 12, 2021	Z-1351-2021	—	open, classified	Due to not having the full complement of biological assessments for all potential patients and as a result the devices are not indicated for use in individuals under the age of 18 years old.
Feb 12, 2021	Z-1323-2021	—	open, classified	Due to complaints of adverse events potentially related to biological safety. The complaints included report of pain and bony abnormalities at the interface between the telescoping nail segments.
Feb 12, 2021	Z-1325-2021	—	open, classified	Due to complaints of adverse events potentially related to biological safety. The complaints included report of pain and bony abnormalities at the interface between the telescoping nail segments.
Feb 12, 2021	Z-1349-2021	—	open, classified	Due to not having the full complement of biological assessments for all potential patients and as a result the devices are not indicated for use in individuals under the age of 18 years old.
Jul 24, 2020	Z-0069-2021	—	open, classified	During explantation, standard removal tools can generate sufficient forces to cause distal plug to disassociate from the bone transport system.
Jun 25, 2019	Z-0528-2022	—	open, classified	Safety Alert to all surgeons informing them of post-implantation fractures of an internal metallic component for device manufactured prior to March 26, 2015.