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Sign in to claim this brandPREMIA SPINE LTD
US
Last updated May 23, 2026
Information
- Country
- US
- Address
- —
- Website
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- —
- —
- —
- Phone
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- PRRC Contact
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- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 649220779
Catalogue (452)
Page 3 of 10| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| ProMIS™ Fixation System | 87497 | FDA UDI | Class II | Active |
| Niti#1 Wire, Blunt Blunt Tip, L=470, Ø1.7mm Over K-Wire | 87010 | FDA UDI | Class III | Active |
| ProMIS™ Fixation System | 87345 | FDA UDI | Class II | Active |
| Tops™ - 38 S | 86002 | FDA UDI | Class III | Active |
| Polyaxial Pedicle Screw | 86123 | FDA UDI | Class II | Active |
| VersaLink™ Fixation System | 87553 | FDA UDI | Class II | Active |
| Distractor | 86601 | FDA UDI | Class II | Active |
| Non-Tapered Pedicle Probe Ø7.5 | 86996 | FDA UDI | Class II | Active |
| VersaLink™ Fixation System | 87525 | FDA UDI | Class II | Active |
| Straight Handle with Pendulum Adaptor | 86273 | FDA UDI | Class III | Active |
| VersaLink Monitor | 87451 | FDA UDI | Class II | Active |
| Niti#2 Wire, Blunt Blunt Tip, L=470, Ø1.5mm Over K-Wire | 87865 | FDA UDI | Class III | Active |
| VersaLink™ Fixation System | 86165 | FDA UDI | Class II | Active |
| Polyaxial Pedicle Screw | 86122 | FDA UDI | Class II | Active |
| Cannulated Tap Ø 6.5 mm | 86143 | FDA UDI | Class II | Active |
| VersaLink™ Fixation System | 87565 | FDA UDI | Class II | Active |
| Non-Cannulated Polyaxial Pedicle Screw | 88522 | FDA UDI | Class II | Active |
| ProMIS™ Fixation System | 87344 | FDA UDI | Class II | Active |
| Polyaxial Pedicle Screw | 86133 | FDA UDI | Class II | Active |
| ProMIS™ Fixation System | 87653 | FDA UDI | Class II | Active |
| Non-Cannulated Polyaxial Pedicle Screw | 88512 | FDA UDI | Class II | Active |
| Curved Distractor | 87000 | FDA UDI | Class II | Active |
| VersaLink™ Fixation System | 86162 | FDA UDI | Class II | Active |
| Distractor for Open Procedure | 87625 | FDA UDI | Class II | Active |
| ProMIS™ Fixation System | 86402 | FDA UDI | Class II | Active |
| Pedicle Awl XL | 87148 | FDA UDI | Class III | Active |
| Pedicle Probe Sharp-Bent | 86882 | FDA UDI | Class II | Active |
| ProMIS™ Fixation System | 87316 | FDA UDI | Class II | Active |
| ProMIS™ Fixation System | 87670 | FDA UDI | Class II | Active |
| Tube for K-wire over a k-wire technique 470mm | 86818 | FDA UDI | Class II | Active |
| VersaLink™ Fixation System | 82875 | FDA UDI | Class II | Active |
| ProMIS™ Fixation System | 86873 | FDA UDI | Class II | Active |
| ProMIS™ Fixation System | 87490 | FDA UDI | Class II | Active |
| VersaLink™ Fixation System | 87532 | FDA UDI | Class II | Active |
| VersaLink™ Fixation System | 82873 | FDA UDI | Class II | Active |
| VersaLink™ Fixation System | 82874 | FDA UDI | Class II | Active |
| Cannulated Tapered Pedicle Screw | 88684 | FDA UDI | Class II | Active |
| Left Alignment Gauge Superior Crossbars Long | 83107 | FDA UDI | Class III | Active |
| ProMIS™ Fixation System | 87493 | FDA UDI | Class II | Active |
| ProMIS™ Fixation System | 87681 | FDA UDI | Class II | Active |
| Swiveling Sleeve | 88107 | FDA UDI | Class II | Active |
| ProMIS™ Fixation System | 87671 | FDA UDI | Class II | Active |
| VersaLink™ Fixation System | 86161 | FDA UDI | Class II | Active |
| VersaLink™ Fixation System | 82578 | FDA UDI | Class II | Active |
| ProMIS™ Fixation System | 87666 | FDA UDI | Class II | Active |
| Left Alignment Gauge Superior Crossbars Medium | 86189 | FDA UDI | Class III | Active |
| Versalink Nut Counter Torque | 82597 | FDA UDI | Class II | Active |
| MIS Cannulated Pedicle Probe | 86047 | FDA UDI | Class II | Active |
| Compressor for Open Procedure | 87624 | FDA UDI | Class II | Active |
| Non-Cannulated Polyaxial Pedicle Screw | 88518 | 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