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Sign in to claim this brandNuVasive Specialized Orthopedics, Inc.
US
Last updated September 17, 2026
What NuVasive Specialized Orthopedics, Inc. makes
NuVasive Specialized Orthopedics manufactures intramedullary nails for femur and tibia, including magnetic distraction systems for limb lengthening and bone transport. Their portfolio also includes non-bioabsorbable orthopedic screws, magnetic distraction plates, and sterile spinal fixation systems for internal stabilization. Reusable orthopedic surgical procedure kits are part of their offerings, alongside magnetic arthrodesis nails for spinal fusion.
The company’s devices are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does NuVasive Specialized Orthopedics, Inc. primarily manufacture?
NuVasive Specialized Orthopedics, Inc. specializes in orthopedic devices, including intramedullary nails for the femur and tibia, such as standard and magnetic distraction systems for limb lengthening and bone transport. Their portfolio also covers non-bioabsorbable orthopedic screws, magnetic distraction plates, sterile spinal fixation systems (like trans-facet-screw systems), and reusable orthopedic surgical procedure kits. Some devices, like the PRECICE® and MAGEC® systems, combine distraction and stabilization for complex orthopedic procedures.
Where is NuVasive Specialized Orthopedics, Inc. based, and how does that affect its regulatory standing?
NuVasive Specialized Orthopedics, Inc. is headquartered in the United States. Since the company operates within the U.S., its devices are subject to FDA regulations, including classification under FDA’s Class I (generally low-risk) and Class II (moderate-risk) categories. The U.S. regulatory framework ensures these devices meet safety and performance standards before entering the market, though individual devices—not the company—are authorized.
Which regulatory registries or databases list NuVasive Specialized Orthopedics, Inc.’s devices?
NuVasive Specialized Orthopedics, Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system provides a standardized way to identify medical devices, ensuring traceability and transparency in regulatory tracking. This listing helps healthcare providers, regulators, and other stakeholders verify device details, such as manufacturer information and classification, but does not imply approval of the company itself.
How are NuVasive Specialized Orthopedics, Inc.’s devices classified under FDA regulations?
NuVasive’s devices fall under FDA’s Class I and Class II classifications. Class I devices are typically low-risk, such as some orthopedic screws or reusable surgical kits, requiring general controls for safety. Class II devices, like magnetic distraction systems (e.g., PRECICE® or MAGEC®), involve moderate risks and require additional performance standards or post-market surveillance to ensure effectiveness and safety. Classification depends on factors like device purpose, risk level, and intended use.
Are NuVasive Specialized Orthopedics, Inc.’s devices used in both limb lengthening and spinal procedures?
Yes, NuVasive’s portfolio includes devices for both applications. For limb lengthening and bone transport, they manufacture intramedullary nails and plates with magnetic distraction (e.g., PRECICE® systems), which gradually lengthen or realign bones. For spinal procedures, their offerings include sterile trans-facet-screw internal fixation systems and magnetic arthrodesis nails (e.g., MAGEC®), designed to stabilize and fuse spinal segments. These devices cater to distinct but specialized orthopedic needs.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- 2560 General Armistead Ave, Audubon, PA, 19403
- Website
- —
- —
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- Phone
- —
- PRRC Contact
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- EUDAMED SRN
- —
- FDA FEI Number
- 3006179046
- DUNS Number
- —
Catalogue (2579)
Page 45 of 52| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| PRECICE® Intramedullary Limb Lengthening System | LSC4-085 | FDA UDI | Class II | Active |
| Precice® Ankle Salvage System | AS11.5-40200-NT | FDA UDI | Class II | Active |
| PRECICE Screws | PSA5-025 | FDA UDI | Class II | Active |
| PRECICE® Intramedullary Limb Lengthening System | PR9.0-50A215 | FDA UDI | Class II | Active |
| PRECICE® STRYDE System | PS10.0-80C265 | FDA UDI | Class II | Active |
| Precice | TPT4-425-S | FDA UDI | Class II | Active |
| PRECICE® Bone Transport System | BT115-80DT320-5 | FDA UDI | Class II | Active |
| PRECICE® Bone Transport System | BT115-10SA400-7 | FDA UDI | Class II | Active |
| PRECICE® Intramedullary Limb Lengthening System Instrument | CRC3-001 | FDA UDI | Class I | Active |
| PRECICE® STRYDE System | STP4.5-375 | FDA UDI | Class II | Active |
| MAGEC Wand | MML-001-C | FDA UDI | Class I | Active |
| PRECICE® Trauma Nail System | T8.5-80C255 | FDA UDI | Class II | Active |
| PRECICE® Intramedullary Limb Lengthening System | PR9.5-80C305 | FDA UDI | Class II | Active |
| Precice | CTN4.5-026-S | FDA UDI | Class II | Active |
| Precice | STP3.5-500-S | FDA UDI | Class II | Active |
| PRECICE® STRYDE System | PS13.0-80X280 | FDA UDI | Class II | Active |
| PRECICE® Bone Transport System | BT13-90V340-5 | FDA UDI | Class II | Active |
| PRECICE® Bone Transport System | BT10-90V340-7 | FDA UDI | Class II | Active |
| Precice | AST11.5-40200-NT | FDA UDI | Class II | Active |
| PRECICE® STRYDE System | PS10.0-80D305 | FDA UDI | Class II | Active |
| PRECICE® Intramedullary Limb Lengthening System | P10.7-80D365 | FDA UDI | Class II | Active |
| Precice | STP3.5-700-S | FDA UDI | Class II | Active |
| PRECICE® Intramedullary Limb Lengthening System | P12.5-80A245 | FDA UDI | Class II | Active |
| PRECICE® Intramedullary Limb Lengthening System | PR9.0-80D275 | FDA UDI | Class II | Active |
| PRECICE® Bone Transport System | BT10-10X400-7 | FDA UDI | Class II | Active |
| PRECICE® STRYDE System | STP4.5-325 | FDA UDI | Class II | Active |
| PRECICE® Bone Transport System | BT10-10E400-7 | FDA UDI | Class II | Active |
| PRECICE® Bone Transport System | BT13-10A360-5 | FDA UDI | Class II | Active |
| PRECICE® Intramedullary Limb Lengthening System Instrument | THF1-000 | FDA UDI | Class I | Active |
| PRECICE® Intramedullary Limb Lengthening System | PR12.5-80E365 | FDA UDI | Class II | Active |
| Precice® | SDAS-6.0 | FDA UDI | Class I | Active |
| Precice | STP4.5-800-S | FDA UDI | Class II | Active |
| PRECICE® Plating System | LP4.5-DRF4B | FDA UDI | Class II | Active |
| PRECICE® Trauma Nail System | CDT11.5C-30T375 | FDA UDI | Class II | Active |
| PRECICE® Intramedullary Limb Lengthening System | ERC 2P | FDA UDI | Class II | Active |
| PRECICE® Intramedullary Limb Lengthening System | PR10.5-80A335 | FDA UDI | Class II | Active |
| PRECICE® STRYDE System | SST-010-000 | FDA UDI | Class II | Active |
| PRECICE® Intramedullary Limb Lengthening System | TSA4.5-055 | FDA UDI | Class II | Active |
| PRECICE® Bone Transport System | BT10-10DT360-7 | FDA UDI | Class II | Active |
| PRECICE® Intramedullary Limb Lengthening System | P8.5-50E230 | FDA UDI | Class II | Active |
| PRECICE® STRYDE System | PS10.0-80E335 | FDA UDI | Class II | Active |
| PRECICE® Trauma Nail System | T8.5-80C315 | FDA UDI | Class II | Active |
| PRECICE® Bone Transport System | BT13-10D380-7 | FDA UDI | Class II | Active |
| PRECICE® STRYDE System | PS10.0-80D265 | FDA UDI | Class II | Active |
| Precice® | DBAS-4.0 | FDA UDI | Class I | Active |
| PRECICE® STRYDE System | PS11.5-65D250 | FDA UDI | Class II | Active |
| Precice | CTL4.5-046-S | FDA UDI | Class II | Active |
| Precice® | SFT4-500-S | FDA UDI | Class II | Active |
| PRECICE® Bone Transport System | BT13-60SB280-6 | FDA UDI | Class II | Active |
| MAGEC® Spinal Bracing and Distraction System | MS2-6070R | 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.
NuVasive Specialized Orthopedics, Inc. has 11 recall records initiated between June 25, 2019, and September 30, 2024, with some classified and others remaining open. The reasons cited include updated usage instructions for age, weight, and device quantity restrictions; potential design, manufacturing, and documentation validation issues; biological safety concerns related to reported pain and bony abnormalities; limitations in biological assessments for pediatric use; potential sterile packaging failures during shelf-life studies; a safety alert regarding fractures in metallic components from pre-2015 devices; and risks of distal plug detachment during explantation procedures.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| 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. |