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Sign in to claim this brandJACE MEDICAL, LLC
US
Last updated May 27, 2026
What JACE MEDICAL, LLC makes
Jace Medical, LLC manufactures orthopaedic fixation devices, including non-bioabsorbable plates for bone stabilization, alignment tools for spinal and implant positioning, and reusable surgical instruments such as pliers, cutters, and screwdrivers. Their portfolio also includes trial implants and sizers for surgical planning, as well as sterilization/disinfection containers for reusable devices.
The company’s products are regulated under FDA classifications, with most devices falling into Class I and Class II categories. These devices are listed in the FDA’s 510(k) and Unique Device Identification (UDI) registries, reflecting their compliance with U.S. medical device regulations.
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 Jace Medical, LLC manufacture?
Jace Medical, LLC specializes in orthopaedic fixation devices. Their portfolio includes non-bioabsorbable fixation plates for stabilizing bones, alignment tools for spinal and implant positioning, reusable surgical instruments like pliers and cutters, and trial implants/sizers for surgical planning. They also produce sterilization/disinfection containers for reusable devices, ensuring compatibility with surgical workflows.
Where is Jace Medical, LLC based?
Jace Medical, LLC is based in the United States. The company’s headquarters and operations are located within the country, aligning its regulatory compliance with U.S. medical device standards.
Which regulatory registries list Jace Medical, LLC’s devices?
Jace Medical, LLC’s devices are listed in the FDA’s 510(k) and Unique Device Identification (UDI) registries. These registries track devices that have undergone the required premarket submissions and UDI compliance processes, ensuring traceability and regulatory oversight.
How are Jace Medical, LLC’s devices classified under FDA regulations?
Jace Medical, LLC’s devices are primarily classified as Class I or Class II under FDA regulations. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve moderate risk and require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use and potential health impact.
What is the purpose of the reusable surgical instruments produced by Jace Medical, LLC?
Jace Medical, LLC’s reusable surgical instruments, such as pliers, cutters, and screwdrivers, are designed to assist surgeons in orthopaedic procedures. These tools enhance precision during tasks like implant positioning, plate bending, and fixation, improving surgical efficiency while maintaining sterility through their reusable and sterilizable design.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- jacemed.com
- —
- —
- [email protected]
- Phone
- 574-306-0355
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 063554875
Catalogue (188)
Page 4 of 4| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| O Plate, 6 Holes, Provisional | 215.114.06 | FDA UDI | Class II | Unknown |
| O Plate, 6 Holes, Concave | 115.604.06 | FDA UDI | Class II | Unknown |
| 10mm Locking Screw | 100.035.10 | FDA UDI | Class II | Unknown |
| 10mm Locking Screw, 6pk | 100.035.10 | FDA UDI | Class II | Unknown |
| Sternalock EZ | 315.010.40 | FDA UDI | Class II | Unknown |
| Sternalock EZ | 115.501.07 | FDA UDI | Class II | Active |
| Base | 315.010.00 | FDA UDI | Class II | Unknown |
| Straight Plate, 6 Holes | 115.402.06 | FDA UDI | Class II | Unknown |
| Bridge Box Plate, 4 Holes, Implant Positioner | 215.203.04 | FDA UDI | Class II | Unknown |
| Plate Cutter | 215.010.40 | FDA UDI | Class I | Active |
| Sternalock EZ | 115.504.12 | FDA UDI | Class II | Active |
| Box Plate, 4 Holes, Convex Implant Positioner | 215.703.04 | FDA UDI | Class II | Active |
| Positioner Caddy, Wide | 315.110.16 | FDA UDI | Class II | Unknown |
| 12mm Locking Screw, 6pk | 100.035.12 | FDA UDI | Class II | Unknown |
| Titan™ Double Wire | 132.641.23 | FDA UDI | Class II | Unknown |
| Monoblock Plate | 100.033.06 | FDA UDI | Class II | Unknown |
| Box Plate Implant Postioner | 215.103.04 | FDA UDI | Class II | Unknown |
| MIS Implant Positioner | 201.057.47 | FDA UDI | Class II | Unknown |
| 10mm Locking Screw, 18pk | 100.035.10 | FDA UDI | Class II | Unknown |
| Titan™ Double Wire | 132.640.23 | FDA UDI | Class II | Unknown |
| Titan™ Double Wire | 132.641.53 | FDA UDI | Class II | Unknown |
| Sternalock EZ | 115.407.24 | FDA UDI | Class II | Active |
| Retaining T15 Hexalobe Driver | 215.010.15 | FDA UDI | Class I | Unknown |
| Straight Plate, 4 Holes, Concave | 115.461.04 | FDA UDI | Class II | Active |
| Plate Screw Guide | 201.025.00 | FDA UDI | Class II | Active |
| Sternalock EZ | 315.210.00 | FDA UDI | Class II | Unknown |
| Manubrium Plate 10 Holes, Implant Positioner | 215.110.10 | FDA UDI | Class II | Unknown |
| Shear Bar Removal Tool | 201.033.10 | FDA UDI | Class I | Unknown |
| Bridge H Plate, 6 Holes | 115.202.06 | FDA UDI | Class II | Unknown |
| Straight Plate, 4 Holes | 115.401.04 | FDA UDI | Class II | Unknown |
| Staight Plate, 4 Holes, Provisional | 215.411.04 | FDA UDI | Class II | Unknown |
| Alignment Instrument, Single End | 201.040.10 | FDA UDI | Class II | Unknown |
| H Plate, 6 Holes | 115.102.06 | FDA UDI | Class II | Unknown |
| Straight Plate, 8 Holes | 115.403.08 | FDA UDI | Class II | Unknown |
| Bridge H Plate, 6 Holes, Implant Positioner | 215.202.06 | FDA UDI | Class II | Unknown |
| Recon Base | 315.110.00 | FDA UDI | Class II | Unknown |
| JACE Medical Thoracic Plating System | K210290 | FDA 510(k) | Class II | Active |
| Sternal Closure System | K142484 | FDA 510(k) | Class II | Active |
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