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Sign in to claim this brandPREMIA SPINE LTD
US
Last updated May 23, 2026
What PREMIA SPINE LTD makes
Premia Spine Ltd manufactures spinal fixation hardware, including cannulated and polyaxial pedicle screws, internal spinal rods, and reusable surgical instruments like guidewires, taps, and distraction tools. Their portfolio also includes reusable orthopaedic and ENT probes, as well as positioning instruments for prosthesis implantation. The company produces torque-limited screwdrivers and reusable surgical handles for spinal and orthopaedic procedures.
The company’s devices are classified under FDA regulations as Class II and Class III, with all products listed in the FDA’s Unique Device Identification (UDI) database. The manufacturer operates from the United States.
Written from this company's registered devices by an AI model, 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
- 649220779
Catalogue (452)
Page 5 of 10| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| VersaLink™ Fixation System | 82579 | FDA UDI | Class II | Active |
| ProMIS™ Fixation System | 87491 | FDA UDI | Class II | Active |
| ProMIS™ Fixation System | 86406 | FDA UDI | Class II | Active |
| ProMIS™ Fixation System | 86243 | FDA UDI | Class II | Active |
| SST 316 LVM, Blunt Beveled Tip, L=230, Ø1.7 ShidiTechnique | 87209 | FDA UDI | Class III | Active |
| Pedicle Probe Sharp Straight | 86880 | FDA UDI | Class II | Active |
| Alignment Gauge handle Long | 83104 | FDA UDI | Class III | Active |
| VersaLink™ Fixation System | 82879 | FDA UDI | Class II | Active |
| ProMIS™ Fixation System | 86244 | FDA UDI | Class II | Active |
| ProMIS™ Fixation System | 87672 | FDA UDI | Class II | Active |
| VersaLink™ Fixation System | 82563 | FDA UDI | Class II | Active |
| ProMIS™ Fixation System | 86872 | FDA UDI | Class II | Active |
| Non-Cannulated Polyaxial Pedicle Screw | 88506 | FDA UDI | Class II | Active |
| ProMIS™ Fixation System | 86242 | FDA UDI | Class II | Active |
| VersaLink™ Fixation System | 87566 | FDA UDI | Class II | Active |
| Polyaxial Pedicle Screw | 86127 | FDA UDI | Class II | Active |
| K-Wire, CrCo, Blunt Sharp Tip, L=340, Ø1.65mm DKWA | 87271 | FDA UDI | Class III | Active |
| Polyaxial Pedicle Screw | 86134 | FDA UDI | Class II | Active |
| Polyaxial Pedicle Screw | 86139 | FDA UDI | Class II | Active |
| ProMIS™ Fixation System | 87663 | FDA UDI | Class II | Active |
| VersaLink™ Fixation System | 87521 | FDA UDI | Class II | Active |
| VersaLink™ Fixation System | 87539 | FDA UDI | Class II | Active |
| MIS reduction Tool reducer | 86500 | FDA UDI | Class II | Active |
| Cannulated Tapered Pedicle Screw | 88683 | FDA UDI | Class II | Active |
| Dynamic K-Wire Adapter | 87130 | FDA UDI | Class II | Active |
| ProMIS™ Fixation System | 87510 | FDA UDI | Class II | Active |
| External Dilator | 86037 | FDA UDI | Class II | Active |
| K-Wire, Blunt Sharp Tip, L=352, Ø1.7mm XL Shidi-Tec | 87284 | FDA UDI | Class III | Active |
| MIS Reduction Tool Tower Connector | 86501 | FDA UDI | Class II | Active |
| VersaLink™ Fixation System | 87556 | FDA UDI | Class II | Active |
| SST 316 LVM, Blunt-Sharp Tip, L=600, Ø1.7 Power Drill | 87447 | FDA UDI | Class III | Active |
| ProMIS™ Fixation System | 87480 | FDA UDI | Class II | Active |
| ProMIS™ Fixation System | 86405 | FDA UDI | Class II | Active |
| VersaLink™ Fixation System | 86166 | FDA UDI | Class II | Active |
| ProMIS™ Fixation System | 87494 | FDA UDI | Class II | Active |
| ProMIS™ Fixation System | 87343 | FDA UDI | Class II | Active |
| Non-Cannulated Polyaxial Pedicle Screw | 88509 | FDA UDI | Class II | Active |
| Tops™ - 30 M | 85859 | FDA UDI | Class III | Active |
| ProMIS™ Fixation System | 86403 | FDA UDI | Class II | Active |
| Non-Cannulated Polyaxial Pedicle Screw | 88503 | FDA UDI | Class II | Active |
| VersaLink™ Fixation System | 86277 | FDA UDI | Class II | Active |
| VersaLink™ Fixation System | 82574 | FDA UDI | Class II | Active |
| Depth Gauge and Feeler | 83210 | FDA UDI | Class III | Active |
| ProMIS™ Fixation System | 86415 | FDA UDI | Class II | Active |
| ProMIS™ Fixation System | 87676 | FDA UDI | Class II | Active |
| ProMIS™ Fixation System | 86241 | FDA UDI | Class II | Active |
| VersaLink™ Fixation System | 87541 | FDA UDI | Class II | Active |
| Cannulated Tapered Pedicle Screw | 88681 | FDA UDI | Class II | Active |
| ProMIS™ Fixation System | 87513 | FDA UDI | Class II | Active |
| K-Wire Adaptor | 86494 | FDA UDI | Class III | Active |
Related Companies
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Premia Spine Ltd. Ramat Poleg, Netanya Central · IL FEI 3012401682