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Sign in to claim this brandPREMIA SPINE LTD
US
Last updated May 23, 2026
Information
- Country
- US
- Address
- —
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
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- DUNS Number
- 649220779
Catalogue (452)
Page 2 of 10| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Non-Cannulated Polyaxial Pedicle Screw | 88510 | FDA UDI | Class II | Active |
| MIS Reduction Tool Knob | 86502 | FDA UDI | Class II | Active |
| ProMIS™ Fixation System | 87656 | FDA UDI | Class II | Active |
| Rod Length Measurement Tool | 86290 | FDA UDI | Class II | Active |
| VersaLink™ Fixation System | 86276 | FDA UDI | Class II | Active |
| VersaLink™ Fixation System | 87523 | FDA UDI | Class II | Active |
| VersaLink™ Fixation System | 87558 | FDA UDI | Class II | Active |
| MIS Compressor | 86300 | FDA UDI | Class II | Active |
| VersaLink™ Fixation System | 86163 | FDA UDI | Class II | Active |
| K-Wire, Blunt Blunt Tip, L=600, Ø1.7mm P.Drill | 87696 | FDA UDI | Class III | Active |
| Rod Pusher | 86604 | FDA UDI | Class II | Active |
| Feeler Gauge - Thick | 87353 | FDA UDI | Class II | Active |
| VersaLink™ Fixation System | 82577 | FDA UDI | Class II | Active |
| SST 316 LVM, Blunt-Beveled Tip, L=470, Ø1.7 over the K-Wire | 87208 | FDA UDI | Class III | Active |
| Curved Pedicle Probe | 86469 | FDA UDI | Class II | Active |
| Polyaxial Pedicle Screw | 86128 | FDA UDI | Class II | Active |
| K-Wire, Blunt Blunt Tip, L=470, Ø1.7mm Over K-Wire | 86830 | FDA UDI | Class III | Active |
| Cannulated Tap Ø6.5 XL | 87150 | FDA UDI | Class III | Active |
| TOPS Loading Base | 86991 | FDA UDI | Class III | Active |
| ProMIS™ Fixation System | 87647 | FDA UDI | Class II | Active |
| Polyaxial Pedicle Screw | 86121 | FDA UDI | Class II | Active |
| UNIFLEX Fork Persuader | 86603 | FDA UDI | Class II | Active |
| VersaLink™ Fixation System | 87179 | FDA UDI | Class II | Active |
| Non-Cannulated Polyaxial Pedicle Screw | 88511 | FDA UDI | Class II | Active |
| Non-Cannulated Polyaxial Pedicle Screw | 88505 | FDA UDI | Class II | Active |
| Cannulated Tapered Pedicle Screw | 88685 | FDA UDI | Class II | Active |
| Reduction Tool Setscrew Inserter | 86503 | FDA UDI | Class II | Active |
| ProMIS™ Fixation System | 87649 | FDA UDI | Class II | Active |
| ProMIS™ Fixation System | 87657 | FDA UDI | Class II | Active |
| TOPS Instrumentation Container | 83117 | FDA UDI | Class III | Active |
| ProMIS™ Fixation System | 86241 | FDA UDI | Class II | Active |
| VersaLink™ Fixation System | 82580 | FDA UDI | Class II | Active |
| Integrated Depth Gauge Knob | 87363 | FDA UDI | Class II | Active |
| ProMIS™ Fixation System | 86245 | FDA UDI | Class II | Active |
| DKWA T- Handle, Coupling Connection | 88168 | FDA UDI | Class II | Active |
| VersaLink Bender | 82584 | FDA UDI | Class II | Active |
| ProMIS™ Fixation System | 86411 | FDA UDI | Class II | Active |
| ProMIS™ Fixation System | 86418 | FDA UDI | Class II | Active |
| VersaLink™ Fixation System | 82621 | FDA UDI | Class II | Active |
| ProMIS™ Fixation System | 87499 | FDA UDI | Class II | Active |
| ProMIS™ Fixation System | 87476 | FDA UDI | Class II | Active |
| VersaLink™ Fixation System | 87528 | FDA UDI | Class II | Active |
| Polyaxial Pedicle Screw | 86136 | FDA UDI | Class II | Active |
| Reduction Torque Handle with Extension | 86641 | FDA UDI | Class II | Active |
| ProMIS™ Fixation System | 87655 | FDA UDI | Class II | Active |
| ProMIS™ Fixation System | 86408 | FDA UDI | Class II | Active |
| VersaLink™ Fixation System | 87563 | FDA UDI | Class II | Active |
| Standard Screwdriver | 83209 | FDA UDI | Class II | Active |
| ProMIS™ Fixation System | 86247 | FDA UDI | Class II | Active |
| VersaLink™ Fixation System | 87560 | 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