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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 7 of 10| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| VersaLink™ Fixation System | 87540 | FDA UDI | Class II | Active |
| ProMIS™ Fixation System | 87674 | FDA UDI | Class II | Active |
| Cannulated T- Silicone Handle with Push Coupling | 87866 | FDA UDI | Class II | Active |
| VersaLink™ Fixation System | 87536 | FDA UDI | Class II | Active |
| ProMIS™ Fixation System | 86417 | FDA UDI | Class II | Active |
| ProMIS™ Fixation System | 87475 | FDA UDI | Class II | Active |
| ProMIS™ Fixation System | 87515 | FDA UDI | Class II | Active |
| VersaLink™ Fixation System | 87567 | FDA UDI | Class II | Active |
| ProMIS™ Fixation System | 87659 | FDA UDI | Class II | Active |
| ProMIS™ Fixation System | 87654 | FDA UDI | Class II | Active |
| ProMIS™ Fixation System | 87349 | FDA UDI | Class II | Active |
| Non-Cannulated Polyaxial Pedicle Screw | 88502 | FDA UDI | Class II | Active |
| ProMIS™ Fixation System | 86404 | FDA UDI | Class II | Active |
| VersaLink™ Fixation System | 82573 | FDA UDI | Class II | Active |
| VersaLink™ Fixation System | 82666 | FDA UDI | Class II | Active |
| VersaLink™ Fixation System | 82570 | FDA UDI | Class II | Active |
| ProMIS™ Fixation System | 86258 | FDA UDI | Class II | Active |
| ProMIS™ Fixation System | 87503 | FDA UDI | Class II | Active |
| VersaLink™ Fixation System | 87981 | FDA UDI | Class II | Active |
| VersaLink™ Fixation System | 87182 | FDA UDI | Class II | Active |
| Pedicle Awl | 83159 | FDA UDI | Class II | Active |
| ProMIS™ Fixation System | 86246 | FDA UDI | Class II | Active |
| Ring Nut Inserter | 82594 | FDA UDI | Class II | Active |
| VersaLink™ Fixation System | 82876 | FDA UDI | Class II | Active |
| ProMIS™ Fixation System | 86407 | FDA UDI | Class II | Active |
| ProMIS™ Fixation System | 87501 | FDA UDI | Class II | Active |
| VersaLink™ Fixation System | 87979 | FDA UDI | Class II | Active |
| ProMIS™ Fixation System | 87487 | FDA UDI | Class II | Active |
| VersaLink™ Fixation System | 87559 | FDA UDI | Class II | Active |
| ProMIS™ Fixation System | 87507 | FDA UDI | Class II | Active |
| VersaLink™ Fixation System | 87533 | FDA UDI | Class II | Active |
| Tops™ - 38 M | 85860 | FDA UDI | Class III | Active |
| Cannulated Tapered Pedicle Screw | 88680 | FDA UDI | Class II | Active |
| Cannulated Tapered Pedicle Screw | 88673 | FDA UDI | Class II | Active |
| Rod Cutter for 6mm | 86296 | FDA UDI | Class II | Active |
| Alignment Gauge handle Medium | 86185 | FDA UDI | Class III | Active |
| Feeler Gauge - Thin | 87352 | FDA UDI | Class II | Active |
| Cannulated Tapered Pedicle Screw | 88677 | FDA UDI | Class II | Active |
| VersaLink™ Fixation System | 87551 | FDA UDI | Class II | Active |
| VersaLink™ Fixation System | 87561 | FDA UDI | Class II | Active |
| VersaLink™ Fixation System | 82567 | FDA UDI | Class II | Active |
| VersaLink Torque Limiter | 87206 | FDA UDI | Class II | Active |
| VersaLink™ Fixation System | 87980 | FDA UDI | Class II | Active |
| VersaLink™ Fixation System | 87547 | FDA UDI | Class II | Active |
| VersaLink™ Fixation System | 87534 | FDA UDI | Class II | Active |
| Torque Limiter | 85836 | FDA UDI | Class II | Active |
| ProMIS™ Fixation System | 87648 | FDA UDI | Class II | Active |
| Straight Pedicle Probe XL | 87272 | FDA UDI | Class III | Active |
| ProMIS™ Fixation System | 87673 | FDA UDI | Class II | Active |
| Head Releaser | 80646 | FDA UDI | Class II | Active |
Related Companies
Authorised Representatives
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Authorities
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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