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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 9 of 10| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| ProMIS™ Fixation System | 87489 | FDA UDI | Class II | Active |
| Polyaxial Pedicle Screw | 86140 | FDA UDI | Class II | Active |
| ProMIS™ Fixation System | 86256 | FDA UDI | Class II | Active |
| PER System 75 | 88990 | FDA UDI | Class II | Active |
| Integrated K-Wire Handle | 86046 | FDA UDI | Class III | Active |
| SST 316 LVM, L=470, Ø1.5 over the K-Wire | 87851 | FDA UDI | Class III | Active |
| Right Alignment Gauge Superior Crossbars Medium | 86187 | FDA UDI | Class III | Active |
| ProMIS™ Fixation System | 87502 | FDA UDI | Class II | Active |
| Polyaxial Pedicle Screw | 86138 | FDA UDI | Class II | Active |
| ProMIS™ Fixation System | 86257 | FDA UDI | Class II | Active |
| Tube for XL instruments | 87259 | FDA UDI | Class III | Active |
| Rod Bender | 86297 | FDA UDI | Class II | Active |
| K-Wire, Blunt Sharp Tip, L=335, Ø1.7mm KWA | 86864 | FDA UDI | Class III | Active |
| Non-Cannulated Polyaxial Pedicle Screw | 88523 | FDA UDI | Class II | Active |
| ProMIS™ Fixation System | 87514 | FDA UDI | Class II | Active |
| ProMIS™ Fixation System | 87650 | FDA UDI | Class II | Active |
| Tops™ - 38 L | 82645 | FDA UDI | Class III | Active |
| Tube for K-Wire 335 mm for direct approach technique | 86819 | FDA UDI | Class II | Active |
| Cannulated Tap Ø5.5 XL | 87151 | FDA UDI | Class III | Active |
| Polyaxial Pedicle Screw | 86124 | FDA UDI | Class II | Active |
| Tops™ - 21 M | 85858 | FDA UDI | Class III | Active |
| ProMIS™ Fixation System | 87498 | FDA UDI | Class II | Active |
| Pedicle Probe XL | 87149 | FDA UDI | Class III | Active |
| ProMIS™ Fixation System | 86244 | FDA UDI | Class II | Active |
| Cutting Guide | 86623 | FDA UDI | Class II | Active |
| ProMIS™ Fixation System | 87669 | FDA UDI | Class II | Active |
| ProMIS™ Fixation System | 87677 | FDA UDI | Class II | Active |
| Non-Cannulated Polyaxial Pedicle Screw | 88519 | FDA UDI | Class II | Active |
| Pendulum | 82775 | FDA UDI | Class III | Active |
| K-Wire, CoCr, Blunt Sharp Tip, L=457, Ø1.7mm XL DKWA | 87446 | FDA UDI | Class III | Active |
| ProMIS™ Fixation System | 87482 | FDA UDI | Class II | Active |
| VersaLink Rod Inserter | 82601 | FDA UDI | Class II | Active |
| Tower - Short Windows | 88112 | FDA UDI | Class II | Active |
| MIS Tower Guide | 86261 | FDA UDI | Class II | Active |
| ProMIS™ Fixation System | 87684 | FDA UDI | Class II | Active |
| ProMIS™ Fixation System | 87478 | FDA UDI | Class II | Active |
| ProMIS™ Fixation System | 86401 | FDA UDI | Class II | Active |
| ProMIS™ Fixation System | 87675 | FDA UDI | Class II | Active |
| Cannulated Pedicle Awl | 86262 | FDA UDI | Class II | Active |
| Distractor | 86299 | FDA UDI | Class II | Active |
| ProMIS™ Fixation System | 87658 | FDA UDI | Class II | Active |
| ProMIS™ Fixation System | 86410 | FDA UDI | Class II | Active |
| Polyaxial Pedicle Screw | 86125 | FDA UDI | Class II | Active |
| ProMIS™ Fixation System | 86414 | FDA UDI | Class II | Active |
| ProMIS™ Fixation System | 86871 | FDA UDI | Class II | Active |
| ProMIS Extension Rod System | K232719 | FDA 510(k) | Class II | Active |
| ProMIS™ Fixation System | K231844 | FDA 510(k) | Class II | Active |
| ProMIS™ Fixation System | K170061 | FDA 510(k) | Class II | Active |
| VersaLink™ Fixation System | K182598 | FDA 510(k) | Class II | Active |
| Premia Spine XL Instruments | K191854 | FDA 510(k) | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
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Notified Bodies
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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