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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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Phone: —
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EUDAMED SRN: —
FDA FEI Number: 3006179046
DUNS Number: —

Catalogue (2579)

Page 3 of 52

Device	Model / Reference	Registries	Class	Status
PRECICE® Trauma Nail System	CDT11.5C-30T300	FDA UDI	Class II	Active
PRECICE® Bone Transport System	BT10-10B400-7	FDA UDI	Class II	Active
PRECICE® STRYDE System	PS11.5-50V235	FDA UDI	Class II	Active
PRECICE® Intramedullary Limb Lengthening System Instrument	AWA1-000	FDA UDI	Class I	Active
PRECICE Screws	PSA5-090	FDA UDI	Class II	Active
PRECICE® Trauma Nail System	T8.5-80E285	FDA UDI	Class II	Active
Precice®	STP6-700-A-S	FDA UDI	Class II	Active
PRECICE® Bone Transport System	BT13-70DT300-7	FDA UDI	Class II	Active
Precice	CTN4.5-014-S	FDA UDI	Class II	Active
Precice®	SFT4-200-S	FDA UDI	Class II	Active
PRECICE® Intramedullary Limb Lengthening System Instrument	LRB1-000	FDA UDI	Class II	Active
PRECICE® Bone Transport System	BT115-10SD400-7	FDA UDI	Class II	Active
PRECICE® Bone Transport System	BT115-80SJ320-5	FDA UDI	Class II	Active
PRECICE® Bone Transport System	BT13-80SD320-5	FDA UDI	Class II	Active
PRECICE® Bone Transport System	BT13-70V300-7	FDA UDI	Class II	Active
Precice	STP4-500-S	FDA UDI	Class II	Active
Precice	TPT4.5-325-S	FDA UDI	Class II	Active
PRECICE® Intramedullary Limb Lengthening System	P10.7-50N160	FDA UDI	Class II	Active
PRECICE® Intramedullary Limb Lengthening System Instrument	THD2-000	FDA UDI	Class I	Active
PRECICE® Plating System	LP4.5-MLT40	FDA UDI	Class II	Active
Precice	TPT4-350-S	FDA UDI	Class II	Active
PRECICE® Bone Transport System	BT13-10A360-7	FDA UDI	Class II	Active
PRECICE® Bone Transport System	BT10-10B400-5	FDA UDI	Class II	Active
PRECICE® Intramedullary Limb Lengthening System	CED1-008	FDA UDI	Class I	Active
PRECICE® Intramedullary Limb Lengthening System	PR12.5-80D245	FDA UDI	Class II	Active
PRECICE® Intramedullary Limb Lengthening System	TSA5-065	FDA UDI	Class II	Active
PRECICE® Bone Transport System	BT13-60DT280-6	FDA UDI	Class II	Active
PRECICE® Trauma Nail System	LBD1-000	FDA UDI	Class I	Active
Precice®	SFT4-250-S	FDA UDI	Class II	Active
Precice®	STP6-900-A	FDA UDI	Class II	Unknown
Precice External Remote Controller	SW0011	FDA UDI	Class II	Active
Precice®	DSA2-001	FDA UDI	Class I	Active
PRECICE® Intramedullary Limb Lengthening System	LSC5-030	FDA UDI	Class II	Active
PRECICE® Trauma Nail System	DBT1-4.3	FDA UDI	Class I	Active
Precice External Remote Controller	ERC 4P	FDA UDI	Class II	Active
Precice	CTL4.5-060-S	FDA UDI	Class II	Active
PRECICE® Intramedullary Limb Lengthening System	P8.5-80B365	FDA UDI	Class II	Active
PRECICE® Bone Transport System	BT13-10X380-5	FDA UDI	Class II	Active
PRECICE® STRYDE System	PS11.5-80V365	FDA UDI	Class II	Active
Precice	CTL4.5-028-S	FDA UDI	Class II	Active
PRECICE® Intramedullary Limb Lengthening System Instrument	DBB5-000	FDA UDI	Class II	Active
PRECICE® Intramedullary Limb Lengthening System	P10.7-80B245	FDA UDI	Class II	Active
PRECICE® STRYDE System	PS11.5-80C305	FDA UDI	Class II	Active
PRECICE® Intramedullary Limb Lengthening System	PR11.5-80D365	FDA UDI	Class II	Active
PRECICE® Intramedullary Limb Lengthening System	HEC4-000	FDA UDI	Class II	Active
PRECICE® Intramedullary Limb Lengthening System	PR9.5-50B230	FDA UDI	Class II	Active
PRECICE® UNYTE Trauma Nail System	T10.7-80A275	FDA UDI	Class II	Active
PRECICE® Trauma Nail System	T8.5-80C375	FDA UDI	Class II	Active
PRECICE® Trauma Nail System	T8.5-80E315	FDA UDI	Class II	Active
PRECICE Screws	PSA4-025	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.