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Sign in to claim this brandNuVasive Specialized Orthopedics, Inc.
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 2560 General Armistead Ave, Audubon, PA, 19403
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3006179046
- DUNS Number
- —
Catalogue (2579)
Page 52 of 52| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| PRECICE® Trauma Nail System | CDT11.5-30T375 | FDA UDI | Class II | Active |
| PRECICE® Instruments | HDL3-000 | FDA UDI | Class I | Active |
| Precice Instrument | KWS1-002 | FDA UDI | Class I | Active |
| Precice External Remote Controller | ERC 3P | FDA UDI | Class II | Active |
| PRECICE® Instruments | SDG3-000 | FDA UDI | Class I | Active |
| PRECICE® Trauma Nail System | T8.5-80D255 | FDA UDI | Class II | Active |
| PRECICE® Instruments | DBS2-4.3 | FDA UDI | Class I | Active |
| PRECICE® Trauma Nail System | TSA5-067.5 | FDA UDI | Class II | Active |
| PRECICE® Instruments | CED2-011 | FDA UDI | Class I | Active |
| Precice Ankle Salvage System | K230765 | FDA 510(k) | Class II | Active |
| PRECICE UNYTE CoCr System | K162927 | FDA 510(k) | Class II | Active |
| Precice® Ankle Salvage System | K200430 | FDA 510(k) | Class II | Active |
| Precice® Bone Transport System | K201567 | FDA 510(k) | Class II | Active |
| PRECICE UNYTE System | K172061 | FDA 510(k) | Class II | Active |
| PRECICE System | K173129 | FDA 510(k) | Class II | Active |
| PRECICE Intramedullary Limb Lengthening System | K170169 | FDA 510(k) | Class II | Active |
| PRECICE STRYDE System | K180503 | FDA 510(k) | Class II | Active |
| MAGEC® System | K201543 | FDA 510(k) | Class II | Active |
| PRECICE Bone Transport System | K193016 | FDA 510(k) | Class II | Active |
| MAGEC® Spinal Bracing and Distraction System | K160352 | FDA 510(k) | Class II | Active |
| External Remote Controller ERC 4P | K202348 | FDA 510(k) | Class II | Active |
| MAGEC® Spinal Bracing and Distraction System | K161751 | FDA 510(k) | Class II | Active |
| PRECICE Plating System | K192181 | FDA 510(k) | Class II | Active |
| PRECICE Intramedullary Limb Lengthening System | K170346 | FDA 510(k)FDA UDI | Class II | Active |
| PRECICE® BONE TRANSPORT™ System | K182170 | FDA 510(k) | Class II | Active |
| PRECICE System | K191336 | FDA 510(k) | Class II | Active |
| Precice Intramedullary Limb Lengthening System | K220234 | FDA 510(k) | Class II | Active |
| PRECICE System | K172628 | FDA 510(k) | Class II | Active |
| Precice® Screws | K193617 | FDA 510(k) | 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. |