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Sign in to claim this brandImplantwise LLC
US
Last updated May 23, 2026
What Implantwise LLC makes
Implantwise LLC manufactures single-use surgical instrument interim-placement holders designed to secure and stabilize implants during surgical procedures. Their portfolio includes specialized grips and clips, such as the SmartSDGrip and DriverClip variants, which are tailored for precise handling of spinal and orthopedic hardware.
These devices are classified as Class I under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. The company operates from the United States, adhering to applicable regulatory standards for surgical accessories.
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 Implantwise LLC manufacture?
Implantwise LLC specializes in single-use surgical instrument interim-placement holders. These devices are designed to securely hold and stabilize implants during surgical procedures, ensuring precision and stability. Their portfolio includes specialized grips like the SmartSDGrip and clips such as the DriverClip variants, which are tailored for spinal and orthopedic hardware applications.
Where is Implantwise LLC based?
Implantwise LLC is based in the United States. The company operates from there while adhering to applicable regulatory standards for the manufacturing and distribution of its surgical accessory devices.
Which regulatory registries list Implantwise LLC’s devices?
Implantwise LLC’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for Class I surgical instruments, including their interim-placement holders like the SmartSDGrip and DriverClip variants.
How are Implantwise LLC’s devices classified under FDA regulations?
Implantwise LLC’s devices fall under Class I classification according to FDA regulations. This classification applies to low-risk surgical instruments, such as their single-use interim-placement holders, which are designed for minimal risk to patients when used as intended.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 095652542
Catalogue (7)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| SmartSDGrip | 7.0 | FDA UDI | Class I | Active |
| DriverClip NBM | NBM. | FDA UDI | Class I | Active |
| DriverClip Universal | Universal | FDA UDI | Class I | Active |
| SmartSDGrip | 6.75 | FDA UDI | Class I | Active |
| SmartSDGrip | 8.75 | FDA UDI | Class I | Active |
| SmartSDGrip | 7.75 | FDA UDI | Class I | Active |
| DriverClip S | S | FDA UDI | Class I | Active |
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