Is this your brand? Sign in to claim ownership.

NuVasive Specialized Orthopedics, Inc.

Last updated September 17, 2026

Information

Country: US
Address: 2560 General Armistead Ave, Audubon, PA, 19403
Website: —
LinkedIn: —
Facebook: —
Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 3006179046
DUNS Number: —

Catalogue (2579)

Page 4 of 52

Device	Model / Reference	Registries	Class	Status
Precice	TPT5-450-S	FDA UDI	Class II	Active
MAGEC® Spinal Bracing and Distraction System	RA002-4545SL70	FDA UDI	Class II	Active
MAGEC® Spinal Bracing and Distraction System	RA002-5555SLR70	FDA UDI	Class II	Active
PRECICE® STRYDE System	PS10.0-80A365	FDA UDI	Class II	Active
PRECICE® Bone Transport System	BT115-10X380-7	FDA UDI	Class II	Active
PRECICE® Bone Transport System	BT115-10A380-5	FDA UDI	Class II	Active
PRECICE® Bone Transport System	BT115-60SA280-6	FDA UDI	Class II	Active
PRECICE® STRYDE System	STP4-225	FDA UDI	Class II	Active
Precice®	STP6-900-B	FDA UDI	Class II	Unknown
PRECICE® Intramedullary Limb Lengthening System	P8.5-50A215	FDA UDI	Class II	Active
PRECICE® Intramedullary Limb Lengthening System	PR11.5-50C215	FDA UDI	Class II	Active
PRECICE® Trauma Nail System	T12.5-80B375	FDA UDI	Class II	Active
PRECICE® Bone Transport System	BT13-80SE320-7	FDA UDI	Class II	Active
Precice®	TRA1-001	FDA UDI	Class I	Active
PRECICE® STRYDE System	PS10.0-80E280	FDA UDI	Class II	Active
PRECICE® Intramedullary Limb Lengthening System	PR11.5-80B275	FDA UDI	Class II	Active
PRECICE® Bone Transport System	BT10-10SD360-7	FDA UDI	Class II	Active
PRECICE® Trauma Nail System	T12.5-50D205	FDA UDI	Class II	Active
Precice	LSC5-200-S	FDA UDI	Class II	Active
PRECICE® Intramedullary Limb Lengthening System	CPA2-015	FDA UDI	Class II	Active
PRECICE Screws	PSA4-027.5	FDA UDI	Class II	Active
MAGEC® Rod Template	MR2-4090T	FDA UDI	Class I	Active
PRECICE® Intramedullary Limb Lengthening System	PR11.5-80E335	FDA UDI	Class II	Active
Precice®	EBAS-3.5	FDA UDI	Class I	Active
PRECICE® Bone Transport System	BT13-10B380-7	FDA UDI	Class II	Active
PRECICE® Trauma Nail System	CDT11.5C-30T240	FDA UDI	Class II	Active
PRECICE® Intramedullary Limb Lengthening System	PR12.5-50C215	FDA UDI	Class II	Active
PRECICE® Bone Transport System	BT115-10SJ380-7	FDA UDI	Class II	Active
Precice	CTL4.5-078-S	FDA UDI	Class II	Active
PRECICE® Trauma Nail System	CDH8.5-80M285	FDA UDI	Class II	Active
PRECICE® Intramedullary Limb Lengthening System	TSA5-037.5	FDA UDI	Class II	Active
PRECICE® Intramedullary Limb Lengthening System	P10.7-80C305	FDA UDI	Class II	Active
Precice	STP3.5-800-S	FDA UDI	Class II	Active
Precice® Instrument	STE1-000	FDA UDI	Class I	Active
PRECICE Osteotome Blade, 12mm	BLD1-012	FDA UDI	Class I	Active
PRECICE® Intramedullary Limb Lengthening System	TSA4.5-550-S	FDA UDI	Class II	Active
Precice	STP5-225-S	FDA UDI	Class II	Active
Precice® Ankle Salvage System	AS11.5-40300	FDA UDI	Class II	Active
PRECICE® Bone Transport System	BT115-70X300-5	FDA UDI	Class II	Active
Precice External Remote Controller	ERC 3P	FDA UDI	Class II	Active
PRECICE® Intramedullary Limb Lengthening System	P12.5-80X275	FDA UDI	Class II	Active
PRECICE® Trauma Nail System	T12.5-80B315	FDA UDI	Class II	Active
PRECICE® Plating System	LP4.5-PRT41	FDA UDI	Class II	Active
Precice	STP4-425-S	FDA UDI	Class II	Active
PRECICE® Specialty Targeting Instrument Set	ITA4-000	FDA UDI	Class II	Active
PRECICE® Bone Transport System	BT10-10D400-7	FDA UDI	Class II	Active
PRECICE® Bone Transport System	BT13-10D360-5	FDA UDI	Class II	Active
PRECICE® Bone Transport System	BT115-RMV01	FDA UDI	Class I	Active
PRECICE® Bone Transport System	BT10-90C340-7	FDA UDI	Class II	Active
Precice	CTN4.5-024-S	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

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.