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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 10 of 10| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| ProMIS Fixation System | K150380 | FDA 510(k) | Class II | Active |
| TOPS System | P220002 | FDA PMA | Class III | Active |
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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