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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 8 of 10| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Non-Cannulated Polyaxial Pedicle Screw | 88501 | FDA UDI | Class II | Active |
| Depth Gauge Tube for screw length | 87725 | FDA UDI | Class II | Active |
| VersaLink™ Fixation System | 87550 | FDA UDI | Class II | Active |
| VersaLink™ Fixation System | 82620 | FDA UDI | Class II | Active |
| Polyaxial Pedicle Screw | 86391 | FDA UDI | Class II | Active |
| Non-Cannulated Polyaxial Pedicle Screw | 88516 | FDA UDI | Class II | Active |
| Pedicle Probe Blunt Straight | 86876 | FDA UDI | Class II | Active |
| Cannulated Tapered Pedicle Screw | 88687 | FDA UDI | Class II | Active |
| ProMIS™ Fixation System | 87506 | FDA UDI | Class II | Active |
| VersaLink™ Fixation System | 87564 | FDA UDI | Class II | Active |
| VersaLink™ Fixation System | 87557 | FDA UDI | Class II | Active |
| Tops™ - 21 L | 82643 | FDA UDI | Class III | Active |
| Cannulated Tapered Pedicle Screw | 88682 | FDA UDI | Class II | Active |
| TOPS Inserter | 82889 | FDA UDI | Class III | Active |
| VersaLink™ Fixation System | 82884 | FDA UDI | Class II | Active |
| ProMIS™ Fixation System | 87505 | FDA UDI | Class II | Active |
| K-Wire, Blunt Sharp Tip, L=450, Ø1.7mm XL KWA | 87302 | FDA UDI | Class III | Active |
| ProMIS™ Fixation System | 87661 | FDA UDI | Class II | Active |
| ProMIS™ Fixation System | 86403 | FDA UDI | Class II | Active |
| Polyaxial Pedicle Screw | 86390 | FDA UDI | Class II | Active |
| ProMIS™ Fixation System | 86413 | FDA UDI | Class II | Active |
| ProMIS™ Fixation System | 86874 | FDA UDI | Class II | Active |
| Pedicle Probe Bent with Drop handle | 86676 | FDA UDI | Class II | Active |
| VersaLink™ Fixation System | 87555 | FDA UDI | Class II | Active |
| ProMIS™ Fixation System | 87509 | FDA UDI | Class II | Active |
| VersaLink™ Fixation System | 87543 | FDA UDI | Class II | Active |
| ProMIS™ Fixation System | 87481 | FDA UDI | Class II | Active |
| Rod Pusher | 83203 | FDA UDI | Class II | Active |
| Straight Handle with Pendulum Adaptor w/o Ratchet | 86802 | FDA UDI | Class II | Active |
| Cannulated Tap Ø 4.5 mm | 87075 | FDA UDI | Class II | Active |
| VersaLink™ Fixation System | 87181 | FDA UDI | Class II | Active |
| VersaLink™ Fixation System | 87178 | FDA UDI | Class II | Active |
| ProMIS™ Fixation System | 87504 | FDA UDI | Class II | Active |
| DKWA Tear Drop Handle, Coupling Connection | 88169 | FDA UDI | Class II | Active |
| T-Handle with Pendulum Adaptor | 86263 | FDA UDI | Class III | Active |
| ProMIS™ Fixation System | 86416 | FDA UDI | Class II | Active |
| Non-Tapered Pedicle Probe for Screws Ø5.5 and Ø6.5 | 86995 | FDA UDI | Class II | Active |
| VersaLink™ Fixation System | 87545 | FDA UDI | Class II | Active |
| Pedicle Awl- Conical | 81708 | FDA UDI | Class II | Active |
| Ring Nut Loading Base | 88668 | FDA UDI | Class II | Active |
| VersaLink™ Fixation System | 87520 | FDA UDI | Class II | Active |
| ProMIS™ Fixation System | 86255 | FDA UDI | Class II | Active |
| K-Wire, Blunt Sharp Tip, L=565, Ø1.6 -0.05 mm P.Drill | 87445 | FDA UDI | Class III | Active |
| Non-Cannulated Polyaxial Pedicle Screw | 88500 | FDA UDI | Class II | Active |
| Tops™ - 30 S | 86001 | FDA UDI | Class III | Active |
| VersaLink™ Fixation System | 82572 | FDA UDI | Class II | Active |
| ProMIS™ Fixation System | 87651 | FDA UDI | Class II | Active |
| VersaLink™ Fixation System | 87530 | FDA UDI | Class II | Active |
| ProMIS™ Fixation System | 87652 | FDA UDI | Class II | Active |
| ProMIS™ Fixation System | 87678 | FDA UDI | Class II | 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